Thursday, September 22, 2016 10:28:57 PM
BMSN*Valuation(s), FDA, & Orphan Drug Thoughts…
Below is a compilation of my posts of which some of the info has been edited to add more clarity, but most of it is as I had originally posted over the past few weeks.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85160997
Significance of BMSN IND & Breast Cancer Treatment News…
Significant for understanding, read the post/link below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84957802
Quote:
... HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
Below is some key info to help investors to understand the importance of this breast cancer treatment news (also looks like their drug will be used to treat prostate cancer too. Within this post, you will be able to see how this news ”potentially” positions BMSN to be able to make billions of dollars per year just from this breast cancer piece alone.
Please, don’t just believe me. Read through this post and do the math yourself.
Below are some links to confirm that there is basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed. One could also Google this data to research to see that such is correctly and vastly considered:
http://www.cdc.gov/cancer/breast/statistics/
http://globocan.iarc.fr/factsheets/cancers/breast.asp
http://www.cancerresearchuk.org/cancer-info/cancerstats/world/breast-cancer-world/
This is very significant and very powerful with understanding this recent news from BMSN’s wholly owned subsidiary Regen BioPharma, Inc. positioning itself to own the patented intellectual property covering a novel means of treating breast cancer by augmenting the immune system using a "gene silencing" approach.
As per the PR…
http://ih.advfn.com/p.php?pid=nmona&article=56463068
Quote:
Provenge is a vaccine for prostate cancer that costs $93,000 per treatment cycle(1) and had sales of $240 million in the last three quarters of 2012, despite only increasing survival by 4.1 months(2). Dendreon's Provenge requires extraction of dendritic cells, a "master cell" of the immune system, and manipulation outside of the body. The technology developed by Professor Min involves "training" of the same dendritic cells inside of the body by administration of specific nanoparticles. Proof of concept of these nanoparticles were published by Professor Min in collaboration with University of California San Diego in the prestigious scientific journal Blood (Zheng et al. Blood. 2009 Mar 19;113(12):2646-54). …
For inquiring minds, Dendreon Corp. trades under the ticker of DNDN on the NASDAQ GS at $5.40+ per share:
http://finance.yahoo.com/q?s=DNDN
If Dendreon’s cancer vaccine/medicine called Provenge that has already been approved by the FDA costs $93,000 per treatment and is considered the best thing out there now for fighting cancer and can generate Revenues of $240,000,000 for just three quarters, then BMSN’s technique for its own cancer medicine under their "gene silencing" approach that’s considered 100% times better can be sold for at least the same $93,000 per treatment or higher upon FDA approval in my opinion which could generate far more in Revenues.
As I had indicated above, there are basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed.
Potential Annual Revenues within the US:
220,000 US New Cases x $93,000 per treatment = $20,460,000,000
Potential Annual Revenues within the World:
1,300,000 Worldwide New Cases x $93,000 per treatment = $120,900,000,000
With keeping things real, please understand that it is not likely that BMSN would treat everyone within the world although the potential to consider such exists. So I would not expect those numbers above although a few billion still would not be out of the question considering that their treatment would apply to a few other types of cancer treatments too.
A more conservative number would be to know that BMSN probably would only be able to treat somewhere in the area of 3,500 patients per year from researching the norm for some other companies on the major market in a fairly perfect world. This means that a more conservative number would be as indicated below…
Potential Annual Revenues from probable amount to receive cancer treatment:
3,500 Probable Amount Treated x $93,000 per treatment = $325,500,000
As you can see, this is in line with what some of the major market stocks/companies are generating from the sale of their treatments. Still, the potential is there to make well above that amount when you start considering treatment for prostate cancer and other cancers. There is roughly an 11% profit Margin for stocks within the Biotech Industry as indicated below:
http://biz.yahoo.com/p/515conameu.html
This makes the above amount of ”potential” Revenues from this breast cancer piece to be about $35,805,000 in Revenues for BMSN as derived below:
$325,000,000 x 11% Net Profit Margin = $35,805,000 in Net Profit/Income
Per the recent 8-K below, the BMSN Outstanding Shares (OS) is 1,035,911,549 shares:
http://www.sec.gov/Archives/edgar/data/1079282/000110262413000003/biomatrix8k.htm
Now consider the formulas below to derive a “potential” ”Fundamental Valuation” for BMSN from its breast cancer drug (the HemaXellerate I™ is a different drug and a valuation is explained further below within this post):
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
So…
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
$35,805,000 Net Profit/Income ÷ 1,035,911,549 OS = .0345 Earnings Per Share (EPS)
I will use the P/E Ratio for this breast cancer drug potential that I used in a previous valuation post for BMSN’s HemaXellerate I™ stem cell drug since it is far more conservative than the current P/E Ratio for the Biotech Industry.
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
.0345 EPS x 57.80 P/E Ratio = $1.99 per share
As stated from this news, which confirms the validity of their approach, this gene silencing therapy was developed through over 1.5 million dollars of grant funding at the University of Western Ontario, Canada. This approach offers the possibility of destroying tumors in a non-toxic manner through leveraging the body's own immune system to recognize the cancer as "foreign" and subsequently eradicating it.
http://ih.advfn.com/p.php?pid=nmona&article=56463068
BMSN & the Merk & Co. Connection…
As per Professor Min…
http://ih.advfn.com/p.php?pid=nmona&article=56463068
Quote:
"For more than a decade our laboratory's focus has been to identify how to use gene silencing in the context of immunology. We are enthusiastic to have partnered with Bio-Matrix' Regen BioPharm. We believe this novel approach in treating breast cancer will greatly enhance outcomes for patients," said Professor Min. "While Dendreon's Provenge cancer vaccine has provided an industry precedent for immunotherapy as a practical alternative in oncology, we believe that our approach is capable at competing both at the cost, and efficacy level."
In my opinion, when BMSN added Dr. Wei-Ping Min to their Scientific Advisory Board, it linked BMSN to be in the eyes of Merk & Co. which trades on the NYSE:MRK at $42.00+ per share.
There is absolutely no way Dr. Wei-Ping Min would associate himself with BMSN unless he knew 100% that BMSN had something very worthy of note to be a part of supporting. Because of Dr. Wei-Ping Min’s credentials, if he believes that BMSN is not a scam and is very real, then I will truly trust his due diligence (DD) to do such too.
Dr. Wei-Ping Min is the inventor of siRNA therapeutics which was bought out by Merk & Co for $13.00 per share:
Quote:
http://articles.marketwatch.com/2006-12-28/news/30873760_1_rna-interference-merck-sirna-therapeutics
Sirna Therapeutics holders OK $1.1 bln acquisition by Merck
SAN FRANCISCO (MarketWatch) -- Sirna Therapeutics Inc. said Thursday that its shareholders have approved the company's acquisition by Merck & Co. (US:mrk). In late October, Merck agreed to acquire San Francisco-based Sirna for $13 a share in cash, or $1.1 billion. Sirna develops therapeutics using RNA interference, which aims to treat diseases by disrupting the expression of disease-causing genes. The transaction is expected to close as soon as reasonably practicable, the company said.
Below is confirmation of BMSN making such a move to add Dr. Wei-Ping Min to their Scientific Advisory Board:
Quote:
http://finance.yahoo.com/news/bio-matrix-regen-biopharma-unit-123000524.html
Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.
Here’s a little bit more about Dr. Wei-Ping Min:
http://www.researchgate.net/publication/8440294_RNA_interference_a_potent_tool_for_gene-specific_therapeutics
More About Dr. Weiping Min, M.D.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85035901
http://regenbiopharma.com/advisory-board.html
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84946297
cowboydancer, with these important BMSN thoughts…
These important BMSN thoughts you have posted are right in line with what I have confirmed from personally speaking with the FDA Office. The info below was taken directly from the FDA website and is what I was personally told by the FDA office…
Guidance for Industry Fast Track Drug Development Programs — Designation, Development, and Application Review
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
On Page 9
On Page 17…
Now everyone should read again an earlier post I made explaining my conversation with the FDA:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84909724
Quote:
InvestorStemCell & All, with BMSN clinical trials...
With what I am about to explain for clarity, please... don't just believe me in what I am saying... please call the FDA Office of Orphan Products Development (OOPD) and ask for yourself. They will confirm that there is a 60 day approval process for drugs that are approved to be an Orphan Drug like I had originally learned from the article of which I had previously reflected within my earlier post.
HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
For clarity... when I created that post, I didn't mean to confuse investors. When I had said... "bypass the lengthy Phase I, II, III, & IV FDA Approval Processes"...
I probably should have clearly stated that instead, there will be some kind of an "accelerated Phase I, II, III, & IV FDA Approval Process" that will be part of BMSN performing some sort of clinical trials.
I was not trying to lead anyone to think that obtaining Orphan Drug Status would automatically permit the side stepping of clinical trials. There has to be some way for BMSN to prove the validity of their drug. When I had personally spoke to the FDA Office of Orphan Products Development (OOPD), I was told that there is a process where there are some clinical trials, but they are accelerated in efforts to try to get the drug out into market with "final" FDA approval within 60 days.
I was also told by the FDA Office of Orphan Products Development (OOPD) that the company will probably have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was not given a time frame, but I was told that the FDA tries to get everything done very quickly.
That "60 day" time frame in my post was originally derived from the link I researched below from my post below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84733882
Quote:
http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
...The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved. ...
v/r
Sterling
This is why I think everyone should also now read all of links again that you posted:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84946297
FDA Small Business Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm
FDA Investigational New Drug (IND) Application
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
FDA What Is an Orphan Drug?
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm
FDA Accelerated Approval
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
FDA Fast Track
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84909724
InvestorStemCell & All, with BMSN clinical trials...
With what I am about to explain for clarity, please... don't just believe me in what I am saying... please call the FDA Office of Orphan Products Development (OOPD) and ask for yourself. They will confirm that there is a 60 day approval process for drugs that are approved to be an Orphan Drug like I had originally learned from the article of which I had previously reflected within my earlier post.
HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
For clarity... when I created that post, I didn't mean to confuse investors. When I had said... "bypass the lengthy Phase I, II, III, & IV FDA Approval Processes"...
I probably should have clearly stated that instead, there will be some kind of an "accelerated Phase I, II, III, & IV FDA Approval Process" that will be part of BMSN performing some sort of clinical trials.
I was not trying to lead anyone to think that obtaining Orphan Drug Status would automatically permit the side stepping of clinical trials. There has to be some way for BMSN to prove the validity of their drug. When I had personally spoke to the FDA Office of Orphan Products Development (OOPD), I was told that there is a process where there are some clinical trials, but they are accelerated in efforts to try to get the drug out into market with "final" FDA approval within 60 days.
I was also told by the FDA Office of Orphan Products Development (OOPD) that the company will probably have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was not given a time frame, but I was told that the FDA tries to get everything done very quickly.
That "60 day" time frame in my post was originally derived from the link I researched below from my post below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84733882
Quote:
http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
...The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved. ...
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84742689
BMSN**More than “1” Drug Coming IMHO…
In my opinion, I think a second drug as a minimum will also be coming from BMSN. I truly believe that a few other medical occurrences were learned from the previous tests that were done on the BMSN HemaXellerate drug for stem cells. I say this because if you read the PR below, you will see that BMSN is now referring to HemaXellerate as HemaXellerate I™ as if there is now more than one:
http://ih.advfn.com/p.php?pid=nmona&article=56150687
This means that we can presume that there is at least ”two” different types of HemaXellerate drugs that does at least ”two” different things to support the field of medicine. This means that if you consider all of what we all have been believing, we can multiply our thoughts and beliefs by ”two” as a minimum.
v/r
Sterling
BMSN**Why a quick FDA Orphan Drug Approval…
Regen BioPharma, a wholly-owned subsidiary of BMSN, has submitted an Investigational New Drug (IND) Application to the FDA nearly two weeks ago for approval of its HemaXellerate I™ stem cell drug to combat Aplastic Anemia. The post below explains why we should be hearing of FDA Approval for Regen BioPharma/BMSN to move forward with their clinical trials within the next 2 to 2 ½ weeks in my opinion:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84424571
First:
Make no mistake about it that 85% of all IND applications move on to begin clinical trials as can be confirmed from the link below. So I think it is very safe to expect IND FDA Approval from this first round of FDA Approvals as this was mentioned within the link below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83323810
Second (or Next):
Next, because of HemaXellerate I™ being eligible for Orphan Drug designation, there will be around a 70% chance that the FDA will give an accelerated approval to bypass the normal lengthy FDA Approval Process of going through Phases I, II, III, & IV that usually lasts many months and years and grant BMSN this final/full FDA Approval to move forward in as little as 60 days. You will read why I say this later within this post. Below is confirmation from the FDA website that HemaXellerate I™ will be classified as an Orphan Drug because of its use to combat Aplastic Anemia:
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=092695
Quote:
http://www.trainforlifeamerica.com/go/enewsletter/health-conditions?id=45
• Aplastic anemia: This is one of the most serious types of anemia. In this serious illness, the body's bone marrow cannot produce enough of certain blood cells: red, white, or platelets. In about half the cases of aplastic anemia, the cause is never known. The known causes range from a hereditary defect, exposure to radiation or toxic chemicals, or effects of certain drugs. Certain viruses and cancers can be the underlying causes as well.
• Aplastic anemia is a less common type of anemia, affecting about one in every 25,000 people per year. It usually affects those between ages 15 and 24 or those over age 60. Both sexes are equally affected.
• Aplastic anemia – If left untreated, aplastic anemia leads to rapid death.
HemaXellerate I™ is BMSN’s stem cell drug to combat Aplastic Anemia. Aplastic Anemia is eligible for Orphan Drug Status which makes HemaXellerate I™ able to get full FDA approval in as little as 60 days to bypass the lengthy Phase I, II, III, IV FDA Approval Processes because of being eligible for Orphan Drug Status. This is because HemaXellerate I™ has been confirmed to be something special enough to save the lives of people who have been diagnosed with Aplastic Anemia which could lead to rapid death. Read below to learn more about the Orphan Drug Designation:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
Because of HemaXellerate I™ being eligible to obtain Orphan Drug Status, this means the following below can work towards benefiting BMSN and its shareholders:
1**60 days or Less Accelerated final/full FDA Approval.
2**Bypass lengthy Phase I, II, III, IV FDA Approval Processes.
3**The FDA has been offering incentives for developing treatments for rare diseases since 1983, when the Orphan Drug Act became law.
4**The FDA wants to double the number of orphan drug designations that their office approves in the next five to 10 years.
5**The Orphan Drug designation comes with a 50 percent tax credit on any clinical trials that need to be conducted.
6**Drug fees, which currently cost around $1.6 million for one drug application, are eliminated.
7**The company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
8**Major medical companies see “confirmed” future value to be 100% on board and supportive.
9**Dr. Cote says the designation brings the new drug to the attention of investors.
Below is a quote from Dr. Timothy Cote:
Quote:
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens.
The U.S. FDA established the Orphan Drug Act (ODA) in January 1983. For those wondering who is Dr. Timothy Cote, he is the doctor that is over the Office of Orphan Products Development. Read below an important article that highlights the importance of Orphan Drugs which supports BMSN in my opinion with quotes from Dr. Timothy Cote:
Quote:
http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
…The FDA has been offering incentives to companies that develop treatments for rare diseases since 1983, when the Orphan Drug Act became law. …
…The FDA's Dr. Timothy Cote thinks there are many more researchers and companies who could benefit from the orphan drug designation. But he says they're often overwhelmed by the regulatory process.
"We have an opacity problem at the FDA. It's a big black box. Nobody knows what they're thinking inside," said Cote. "And we're smashing that black box. We're making it transparent and we're showing people that what we're doing is reasonable, that we don't bite, and we are just as interested in getting new drugs for people with rare diseases as the sponsors are."
Rare conditions are often described as orphan diseases when there are very few treatment options, largely due to a lack of money for drug research. There are about 7,000 known orphan diseases in the U.S.
Cote, who directs the Office of Orphan Products and Development, says most of those diseases have no approved treatment. For that reason, he wants to double the number of orphan drug designations that his office approves in the next five to 10 years. …
… The designation comes with a 50 percent tax credit on any clinical trials that need to be conducted. Drug fees, which currently cost around $1.6 million for one drug application, are eliminated. And a company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
But more than that, Cote says the designation brings the new drug to the attention of investors.
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens. That is how it has tended to work for a lot of these companies." …
… The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved.
Video of FDA Dr. Timothy Cote - Office of Orphan Products Development:
http://www.youtube.com/watch?v=-sKFl5lAmJE
To further add, I think these posts below by other BMSN investors are very wise to consider too by jjr04001, Zer0Veritas, and T_T23 which helped me to further educate myself on the thoughts I derived above:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84669948
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84670129
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84671685
The poster named jjr04001 is a Pharmacist. So in my opinion, jjr04001 is more qualified than me and your average investor here which lacks any medical qualifications. Much was articulately explained by jjr04001. It was articulately explained how that with HemaXellerate I™ being a treatment for Aplastic Anemia, Aplastic Anemia is a disease which can be described currently as lacking a profit motive because of how rare the disease is and because of how expensive it is to treat. It was articulately explained to look at some of the antiviral treatments for HIV/AIDS (Glaxo's Lexiva - Fosemprenavir) or Genzyme's Fabrazyme (Agalsidase beta) to see how they did not go through 8 years of clinical trials.
Most important in my opinion to note, it was articulately explained that an orphan drug, historically, has an 83% chance of approval to phase II clinical trials, as compared to 33% for non-orphan drugs. Further, Aplastic anemia, if left untreated, WILL kill in 7 months or less. Deaths from this disease are generally quick. "Orphan drug status" is the key here. These drugs are an exception to normal regulatory pre-marketing practices. Treatments for "Orphan diseases" are a guaranteed profit as the patient is a chronic patient, always requiring therapy, payers usually had no problem covering these treatments because of how rare the diseases are, and there are incentives given federally to reduce sales cost and what have you...
Then, it was articulately explained that if you go on the website for national institute of health (NIH) and type in hemaxellerate, you will find a mechanism of the treatment and to then compare this treatment to the current modes of treatment for Aplastic Anemia (Immunosuppression, bone marrow transplant, ATG/ALG, steroids) and compare the side effects/ efficacy / safety and survival rates. Based on the professional judgment of jjr04001 (PharmD.) this treatment has a lot to offer to those who suffer from this debilitating disease (often children).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3543295/
Below is more on the benefits provided for qualifying to be an Orphan Drug:
Quote:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/02/fda-orphan-drug-designations-are-on-the-rise.html
Orphan drug designation qualifies a company for several benefits under the ODA, as amended. These benefits include a 7-year period of orphan drug exclusivity upon product approval (which generally prevents FDA from approving another firm’s version of the “same drug” for the same disease or condition for 7 years), a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.
Again, Federal Grants can be given to support Orphan Drugs as explained below:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
The above is why I truly believe in the post below elaborating why I feel that BMSN has potential to be trading in the $1.19 per share range and possibly sooner than what any of us think:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83394755
v/r
Sterling
I think what some are not seeing just yet with BMSN and its HemaXellerate I™ stem cell drug, is that its competitor drugs,Neupogen®, Neulasta®, Leukine® and Revolade®, are generating over $500 Million in Revenues alone. To understand the magnitude of this, read the DD post below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84424571
To significantly add... HemaXellerate I™delivers an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche of which the other drugs apparently do not deliver such. This is what will make HemaXellerate I™ different and better than those other drugs.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84424571
Why Expect BMSN FDA Approval of IND App...
At times, some people fail to realize that within the penny stock world, it’s not all about where you have been as a company… it’s all about where you are going. BMSN appears to be truly going some places in some major ways.
Per the FDA link below, they will review the Investigational New Drug (IND) application filed with the FDA by BMSN (Regen BioPharma a wholly-owned subsidiary of BMSN) and yes, after not having any comments within 30 days after submission (about 24 now remaining), BMSN could move forward with their goal to initiate clinical trials assessing the company's HemaXellerate I™ stem cell drug in patients:
Quote:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
In my opinion, I believe that BMSN will not have any issues because of their TEAM that they have put together to be a part of their Scientific Advisory Board. I’ll further elaborate below.
Below is a post that reflects how BMSN could very easily have some huge Merk & Co. connection since the addition of Dr. Wei-Ping Min to their Scientific Advisory Board:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84165590
Below is a post of BMSN & Cromos Pharma confirmation:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84305036
The CEO of Cromos Pharma is Dr. Vladimir Bogin of which the post below indicates his significant qualifications courtesy of Jobrano:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84415540
Dr. Vladimir Bogin’s comment from the BMSN PR is below along with other key thoughts to add to further affirmation of the advantages of HemaXellerate I™ over other drugs selling within the market:
Quote:
http://ih.advfn.com/p.php?pid=nmona&article=56150687
If the clinical trial is successful, the company plans to expand use of HemaXellerate I™ to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market. This market is substantial in size and currently includes drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®.
"Current drug-based approaches for healing bone marrow damage involve "flooding" the body with growth factors, which is extremely expensive and causes unintended consequences because of lack of selectivity," said Dr. Vladimir Bogin, CEO of Chromos Pharma (a contract research organization), which collaborated with Regen on filing the IND and member of the Company's Scientific Advisory Board. "Based on our data HemaXellerate I™ possesses the advantage delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche." …
So, to better put this, based on Dr. Vladimir Bogin, the CEO of Cromos Pharma and the rest of the BMSN Scientific Advisory Board, HemaXellerate I™ will be better and outperform Neupogen®, Neulasta®, Leukine® and Revolade® because of delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche of which the other drugs apparently do not deliver such.
To get an understanding of what this means, read the PR & info below to get an idea of the revenues that are generated from its competitors with a less capable drug:
Quote:
http://www.reuters.com/article/2012/08/29/us-teva-idUSBRE87S1CV20120829
…Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta, the biotech company's longer-lasting white blood cell booster, were $3 billion. …
To add, for inquiring minds, Neupogen® and Neulasta® is owned by Amgen Inc. which trades on the NASDAQ under the ticker of AMGN at $86.00+ per share.
http://www.amgen.com/
Amgen, Inc. (AMGN:NASDAQ) has various collaborative arrangements with Pfizer Inc.; Glaxo Group Limited; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; DaVita Inc.; Fresenius Medical Care North America; Cytokinetics, Inc.; Kirin-Amgen, Inc.; and AstraZeneca Plc.
This is one of many reasons why I truly believe that BMSN will be getting a major Collaboration Agreement for their HemaXellerate I™ stem cell drug from a major Pharma company.
And with Revolade®, which is owned by U.K.-based GlaxoSmithKline PLC which trades under the ticker of GSK on the NYSE at over $45.00+ per share:
Quote:
http://www.advfn.com/nyse/StockNews.asp?stocknews=GSK&article=41953195
Analysts expect the medicine to generate worldwide sales of $260 million in 2012, according to consensus forecasts from Thomson Pharma.
Now read again, the DD previously posted below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83984795
BMSN Summarized DD to Consider...
Here's some solid BMSN due diligence (DD) in my opinion that I have summarized to hopefully help investors to understand why I feel as confident in BMSN as I do.
http://www.regenbiopharma.com/
Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (OTCBB: BMSN), is a biotechnology company focused on identifying undervalued regenerative medicine applications in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials.
The BMSN/Regen BioPharma Business Model:
http://www.youtube.com/watch?feature=player_embedded&v=0ILddpeLDh8
Bio-Matrix Scientific Group, Inc. Announces Newly Formed Stem Cell Subsidiary -- Regen BioPharma Inc., Secures $20,000,000 in Institutional Funding from Southridge Partners II LP
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-123000672.html
http://www.southridge.com/
http://www.southridge.com/southridge-news-and-events/
Regen BioPharma Unveils Plan for Value Optimization of Nascent Stem Cell Patents
http://finance.yahoo.com/news/bio-matrix-subsidiary-first-class-123000403.html
Month 1-2: Assembly of Team. Completed Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization.
Month 1-4: In-licensing of Intellectual Property. Completed The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development.
Month 3-6: Interaction with Regulatory Agencies. CompletedRegen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials.
Month 6-18: Clinical Implementation. Partly CompletedRegen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy.
Month 18-24: Exit. Currently in ProcessIt is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.
"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."
BMSN Hires J. Christopher Mizer as President and Chief Operating Officer of its Regen BioPharma subsidiary
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-123000923.html
Mr. Mizer is the founder of Vivaris, Ltd., a private investment partnership focused on life science and healthcare opportunities, and co-founder of ChinaBio Capital Partners. He was formerly an investment banker with Key Capital Markets and a consultant with Ernst and Young. He holds a Master of Science degree in biology and an M.B.A. from Case Western Reserve University.
http://www.chinabiollc.com/
We have organized more than 20 conferences in China, the U.S. and Europe, and have generated more than $450M in funding for our participants and clients.
http://www.vivarisltd.com/
We seek companies located across the U.S. with sales between $5.0 million to $50.0 million and an EBITDA of $0.5 million to $10.0 million. We prefer companies that are historically profitable and well managed with well-defined markets, a strong reputation for quality, and a commitment to customer service.
Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in Anticipation of Beginning Clinical Development Stem Cell Studies
http://finance.yahoo.com/news/bio-matrix-regen-biopharma-unit-123000524.html
• World renowned experts to accelerate development of stem cell therapeutics
• Regen anticipates new relationship with Clinartis to fast track clinical studies
Bio-Matrix Scientific Group (BMSN) (BMSN) announced today that its Regen BioPharma unit has appointed three internationally renowned regenerative medicine experts to its Scientific Advisory Board (SAB). The new SAB members appointed are David White, M.D., PhD; Wei-Ping Min, M.D., PhD and Vlad Bogin, M.D.
Regen BioPharma has also entered into a Letter of Intent with Clinartis LLC, a global contract research organization (CRO). Clinartis is a full service global CRO serving pharmaceutical, biotech and medical device companies to support Phase I - IV drug and device clinical trials in the US and Europe.
The SAB and Clinartis will assist the Company in its acquisition of intellectual property related to stem cells, translation of the intellectual property into treatments, and optimizing the value of these new therapies.
http://www.clinartis.com/News.asp
Clinartis has entered into a Letter of Intent with Regen BioPharma, a biotechnology company focused on the development translational medicine platforms for the rapid commercialization of stem cell therapies.
Bio-Matrix Scientific Group's Regen BioPharma Subsidiary Executes Option Agreement to License Stem Cell Intellectual Property
http://finance.yahoo.com/news/bio-matrix-scientific-groups-regen-123000589.html
BMSN’s wholly owned subsidiary Regen BioPharma, Inc. has executed an exclusive option agreement which grants Regen BioPharma an option to license Patent #6,821,513 which patents methods of stimulating blood production in patients with deficient stem cells. The patent, as well as data licensed with the patent, covers methods of stimulating the bone marrow to generate new blood cells.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6,821,513.PN.&OS=PN/6,821,513&RS=PN/6,821,513
Bio-Matrix Scientific Group Announces David Audley, the Founder of International Cellular Medicine Society, Has Joined the Advisory Board of Its Regen BioPharma Subsidiary
http://finance.yahoo.com/news/bio-matrix-scientific-group-announces-183200161.html
http://www.cellmedicinesociety.org/
As executive director and CEO of the International Cellular Medicine Society (ICMS), Mr. Audley has spearheaded development and implementation of global guidelines for accreditation of stem cell clinics. Under his leadership, the ICMS has grown from a loose association of a handful of physicians to a major international standards organization with over 3500 members from 36 countries. He is a strong advocate for stem cell therapy development and implementation, and is the chief architect of the ICMS accreditation program that is currently evaluating the practices of nearly 20 facilities in a dozen countries.
"Mr. Audley has made a substantial impact in the clinical translation of stem cell therapeutics by establishing standards, accreditations, an Institutional Review Board (IRB), and partnerships with major organizations such as the AABB,"
Bio-Matrix Scientific Group, Inc. Recruits Senior Scientist for Its Regen BioPharma Subsidiary
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-123000175.html
Thomas E. Ichim, PhD has joined the management team of its Regen BioPharma, Inc. subsidiary as Chief Scientific Officer and Director of Research.
Dr. Ichim is one of the leading authorities in the world on stem cell biology. To date, he has published 82 peer-reviewed articles and is co-editor of the textbook RNA Interference: From Bench to Clinical Translation.
** He is also inventor on over 30 patents and patent applications.
** He currently serves as the CEO of Medistem, Inc.
http://medisteminc.com/
** Was formerly chief of scientific development, and is the scientific founder / co-founder of Medvax Pharma, ToleroTech, bioRASI, and OncoMune.
http://www.tolerotech.com/
ToleroTech is an emerging siRNA company focusing on treatment of immune-associated diseases through immunomodulation using gene-specific silencing technologies.
http://biorasi.com/site/
bioRASI accelerates the process of obtaining FDA approvals with a full spectrum of services, including:
* Program Optimization
* Project Management
* Regulatory
* Clinical
* Data Management & Analysis
* Compliance & Audit
http://biorasi.com/oncomune
OncoMune develops targeted cancer therapeutics through focusing on a newly-discovered, epigenetic transcription factor called Brother of the Regulator of Imprinted Sites (BORIS). This protein is expressed in all cancers tested to date and coordinates expression of numerous downstream genes that give cancer its properties of immortality, metastasis, and uncontrolled growth.
Bio-Matrix Scientific Group, Inc. Announces Participation in the 2012 Stem Cell Meeting on the Mesa's Investor and Partnering Forum
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-140000251.html
http://stemcellmeetingonthemesa.com/
Bio-Matrix' Regen BioPharma Initiates Pre-Clinical Study in Support of HemaXellerate(TM) Cell Therapy
Company Also Developing Two Solutions for Restoring Blood Production That Lack the Adverse Effects of Current Bone Marrow Stimulating Growth Factors
http://finance.yahoo.com/news/bio-matrix-regen-biopharma-initiates-133000984.html
BMSN announced today that its wholly owned subsidiary, Regen BioPharma, Inc., has contracted Cascade Life Sciences, Inc. to research the safety and efficacy of Regen's HemaXellerate™ product using mice models for testing.
Quote:
CASCADE LIFESCIENCES
http://www.ohsu.edu/xd/research/techtransfer/startups/2008-ohsu-startup-companies.cfm
The inspiration for Cascade Life sciences grew from the work of OHSU’s Shoukhrat Mitalipov, PhD. Dr. Mitalipov’s laboratory at the Oregon National Primate Research Center (ONPRC) was the first to successfully create monkey embryonic stem cells using a technique known as somatic cell nuclear transfer (SCNT). The technique may advance health care research and discovery and help lead to therapeutic stem cell products to combat numerous human diseases.
Cascade Lifesciences is a privately-owned San Diego-based company with a platform of stem cell related technologies that are being advanced to serve the research community and the commercial development of stem cell-based therapeutics.
…The results of Regen's study will provide the safety profile data required for filing of an Investigational New Drug (IND) application for the product with the US Food and Drug Administration . Regen intends to file an IND Application in the fourth quarter of 2012 and conduct Phase I/II clinical trials during 2013 and 2014.
HemaXellerate™ offers the possibility of delivering a population of endothelial cells to restore blood production in patients with hematological conditions. …
…Regen has submitted two provisional patent applications covering the use of different sources of endothelial cells to heal damaged bone marrow. These applications cover: (1) placental cells (61/648898 - Acceleration 0f Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells); and (2) fat cells (61/670791 - Treatment of Hematopoietic Disorders). …
http://www.regenbiopharma.com/our-approach.html
BMSN SEC Filings:
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001079282&owner=exclude&count=40&hidefilings=0
http://finance.yahoo.com/q/sec?s=BMSN+SEC+Filings
The below BMSN Fundamental Valuation elaborates as to why I believe that BMSN has the ”potential” to trade in the area $1.19 per share:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83394755
Important for BMSN to trade at the above explained $1.19 per share is for BMSN to maintain being current with their filings on the OTCQB/SEC and if they obtain their FDA Letter. If these things happen, then there are some chances that BMSN ”could” begin heading in that direction over time or even sooner than what some might realize. Still, I like our odds as BMSN shareholders.
To close, below is an example to verify that BMSN trading in the $1.19 per share area is very doable if the company delivers the substance that we all have been expecting:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83431144
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84305036
BMSN & Cromos Pharma Confirmation...
Click on the link below to see confirmation of Cromos Pharma being an active partner of BMSN's recent news of filing an Investigational New Drug (IND) application with the FDA for the stem cell drug HemaXellerate I™ as per Cromos Pharma CEO Dr. Vladimir Bogin.
BMSN’s News with Cromos Pharma of IND application with the FDA:
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Cromos Pharma News with BMSN of IND application with the FDA:
http://cromospharma.com/?id=62
v/r
Sterling
Within the market, there is always a chance for dilution. Let’s not forget that the reason why any stock exists to trade within the market is to use their shares as leverage to raise capital or to provide support to grow the company. Like I have explained before, there is ”good dilution” and ”bad dilution” within the market.
However, any previous dilution done by BMSN has been done to grow the company. This was good dilution. I believe that it is totally foolish to ignore the previous $20,000,000 in Institutional Funding news for BMSN a while back as you can read below which could very easily position all dilution in BMSN to potentially cease:
Quote:
Bio-Matrix Scientific Group, Inc. Announces Newly Formed Stem Cell Subsidiary -- Regen BioPharma Inc., Secures $20,000,000 in Institutional Funding
http://www.regenbiopharma.com/pdf/regen-release-4-30-201.pdf
http://ih.advfn.com/p.php?pid=nmona&article=52208602
Again, as I had previously stated, please, do not use or consider such valuation post to be the gospel for where BMSN is going. Use it as a framework to have in your hip pocket to understand where BMSN could very well go ”just-in-case” BMSN deliver the goods. You will have to use the ”Substitution Property” to replace any variable that may change.
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83394755
A Very Likely $1.19 BMSN Fundamental Valuation…
Before I explain how ”logically” BMSN could ”Fundamentally” be worth trading in the $1.19 per share area, I think it fair to first understand some of the key variables that I will use to help me to derive this ”Fundamental Valuation” for BMSN.
Look within the Yahoo link below and you will see that BMSN trades within the Biotechnology Industry that exists within the Healthcare Sector:
http://finance.yahoo.com/q/pr?s=bmsn
Within the Biotechnology Industry, stocks that are fully reporting and file with the SEC have a Net Profit Margin % of 11.90% and a Price to Earnings (P/E) Ratio of 57.80 as indicated within the Yahoo Finance database as confirmed below:
http://biz.yahoo.com/p/515conameu.html
Read the post below to fully understand the importance of the P/E Ratio:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57154170
Now consider below that it has been indicated that BMSN is seeking to enter into an $18 billion market for bone marrow stimulating growth factors as indicated below since beginning the development of its first clinical product (HemaXellerate™) which is a cellular drug designed to heal damaged bone marrow:
http://www.prweb.com/releases/2012/10/prweb9972993.htm
The question now is… Do you believe that BMSN would be able to achieve at least 1% of that $18 Billion market if they obtain their FDA Letter? The answers is… Yes, no doubt! However, for the purposes of this valuation, I will remain conservative and figure that BMSN would only be able to achieve obtaining only 1% of that $18 Billion market so that investors could understand the magnitude of the true potential that would then exist in BMSN…
1% of $18,000,000,000 = $180,000,000 in Revenues
$180,000,000 x 11.90% Net Profit Margin = $21,420,000 in Net Profit/Income
Per the recent 8-K below, the BMSN Outstanding Shares (OS) is 1,035,911,549 shares:
http://www.sec.gov/Archives/edgar/data/1079282/000110262413000003/biomatrix8k.htm
Now consider the formulas below to derive a “potential” ”Fundamental Valuation” for BMSN:
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
So…
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
$21,420,000 Net Profit/Income ÷ 1,035,911,549 OS = .0206 Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
.0206 EPS x 57.80 P/E Ratio = $1.19 per share
This means that given the above fundamental variables, the expected price per share could be justified to be trading within the $1.19 per share range for BMSN if BMSN is only able to capture only 1% of its $18 Billion market of which it exists.
If you believe that BMSN would capture still an amount far less than 1% of the $18 Billion market to let’s say maybe ”half” of the 1% of the $18 Billion market, then the expected price per share could be justified trading within the .59 per share range for BMSN.
On the contrary, if you believe that BMSN is going to capture far more than 1% of the $18 Billion market, then for every 1% that you believe it would obtain from the $18 Billion market… then you can ”fundamentally” add $1.19 per share for each 1% of expectation. Example below:
1% of $18 Billion Market = $1.19 per share for BMSN
2% of $18 Billion Market = $2.38 per share for BMSN
3% of $18 Billion Market = $3.57 per share for BMSN
4% of $18 Billion Market = $4.76 per share for BMSN
5% of $18 Billion Market = $5.95 per share for BMSN
And so on… and so on… etc.
With this valuation post, it is like any other valuation post that I have made in that it will not be up to what I post or say in order for these price levels to be achieved. It will be up to the company to deliver the ”substance” that we all here are expecting to be the stimulus for such to transpire. Here with BMSN, that primary substance that should act as the stimulus would be the FDA Letter. If BMSN delivers the FDA Letter to the public, then it is very possible that any of the valuations above by themselves or combined could happen.
Please, do not use or consider this post to be the gospel for where BMSN is going. Use it as a framework to have to understand where BMSN could very well go ”just-in-case” BMSN deliver the goods.
Before closing, there is something else very important to note… BMSN trades on the OTCQB. This means that they are fully reporting and file their financials with the SEC. This also means that they have ”audited” financials already acclimated with its existence.
BMSN SEC Filings:
http://finance.yahoo.com/q/sec?s=BMSN+SEC+Filings
http://www.otcmarkets.com/stock/BMSN/company-info
http://www.otcmarkets.com/companies-advisors/otcqb
Bottom line, obtaining the FDA Letter is key, but of course it will also be important for BMSN to remain current and qualified on the OTCQB venture marketplace too. This means that BMSN is very legit and very transparent. The more investors learn of BMSN and its potential, the more significant growth that will be achieved for BMSN.
With BMSN, there are the following key things that investors are expecting to continue the move northward…
1**Filing of 10Q/K
2**Pending FDA IND Application News
3**Research & Safety Data News
4**Phase I & II Clinical Trial Update News
5**Merger News to bring even more valuation
BMSN Website:
http://www.bmsn.us/
v/r
Sterling
Each stock will do what it will do based on its own merit and not whether or not I post a valuation about it or not. There is absolutely no way you can stereotype the bad in one stock with different managements, different filings, etc. and try to believe that whatever outcome that transpired over there will happen over here with BMSN. To do such is totally foolish.
Since you want to compare BMSN to something, why not compare BMSN to one of the last Biotech stocks that I was in, VKNG, a while ago back when it was at .002 per share:
http://investorshub.advfn.com/boards/memberpoststoboard.aspx?userid=1551&boardid=10896
I "originally" mentioned VKNG at .002 per share (had to get .003 though & higher). Later, VKNG had gone to $1.10 per share. VKNG later stabilized in the .25+ per share area where later VKNG was bought out for .27 per share by CONMED Corporation which trades on the NASDAQ under the ticker CNMD at $28.00+ per share as indicated below:
http://ih.advfn.com/p.php?pid=nmona&article=54279009
My point, which is contrary to yours, is that you just never know as like with VKNG, BMSN do have a history of having ”audited” financials. I am not expecting much from the BMSN upcoming financials, but it is basically nothing more than a formality to maintain being current with their filings with the SEC since BMSN is fully reporting and trade on the OTCQB. I am expecting to see their financials released sometime after the market closes today at the latest.
BMSN is very different than the stocks of which you are referring. I am not saying that BMSN is going to be the next VKNG, but I am saying that you just never know. I do believe that BMSN has more potential than VKNG and since VKNG went to $1.10 without obtaining 1% of its market, BMSN could actually get to such level without ever obtaining that 1% from their market anytime soon. If BMSN obtains their FDA Letter, then the sky will be the limit. This will be when the stars will really begin to align."
v/r
Sterling
Below is a compilation of my posts of which some of the info has been edited to add more clarity, but most of it is as I had originally posted over the past few weeks.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85160997
Significance of BMSN IND & Breast Cancer Treatment News…
Significant for understanding, read the post/link below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84957802
Quote:
... HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
Below is some key info to help investors to understand the importance of this breast cancer treatment news (also looks like their drug will be used to treat prostate cancer too. Within this post, you will be able to see how this news ”potentially” positions BMSN to be able to make billions of dollars per year just from this breast cancer piece alone.
Please, don’t just believe me. Read through this post and do the math yourself.
Below are some links to confirm that there is basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed. One could also Google this data to research to see that such is correctly and vastly considered:
http://www.cdc.gov/cancer/breast/statistics/
http://globocan.iarc.fr/factsheets/cancers/breast.asp
http://www.cancerresearchuk.org/cancer-info/cancerstats/world/breast-cancer-world/
This is very significant and very powerful with understanding this recent news from BMSN’s wholly owned subsidiary Regen BioPharma, Inc. positioning itself to own the patented intellectual property covering a novel means of treating breast cancer by augmenting the immune system using a "gene silencing" approach.
As per the PR…
http://ih.advfn.com/p.php?pid=nmona&article=56463068
Quote:
Provenge is a vaccine for prostate cancer that costs $93,000 per treatment cycle(1) and had sales of $240 million in the last three quarters of 2012, despite only increasing survival by 4.1 months(2). Dendreon's Provenge requires extraction of dendritic cells, a "master cell" of the immune system, and manipulation outside of the body. The technology developed by Professor Min involves "training" of the same dendritic cells inside of the body by administration of specific nanoparticles. Proof of concept of these nanoparticles were published by Professor Min in collaboration with University of California San Diego in the prestigious scientific journal Blood (Zheng et al. Blood. 2009 Mar 19;113(12):2646-54). …
For inquiring minds, Dendreon Corp. trades under the ticker of DNDN on the NASDAQ GS at $5.40+ per share:
http://finance.yahoo.com/q?s=DNDN
If Dendreon’s cancer vaccine/medicine called Provenge that has already been approved by the FDA costs $93,000 per treatment and is considered the best thing out there now for fighting cancer and can generate Revenues of $240,000,000 for just three quarters, then BMSN’s technique for its own cancer medicine under their "gene silencing" approach that’s considered 100% times better can be sold for at least the same $93,000 per treatment or higher upon FDA approval in my opinion which could generate far more in Revenues.
As I had indicated above, there are basically around 220,000+ new cases of breast cancer in the US and 1,300,000+ new cases of breast cancer worldwide that are diagnosed.
Potential Annual Revenues within the US:
220,000 US New Cases x $93,000 per treatment = $20,460,000,000
Potential Annual Revenues within the World:
1,300,000 Worldwide New Cases x $93,000 per treatment = $120,900,000,000
With keeping things real, please understand that it is not likely that BMSN would treat everyone within the world although the potential to consider such exists. So I would not expect those numbers above although a few billion still would not be out of the question considering that their treatment would apply to a few other types of cancer treatments too.
A more conservative number would be to know that BMSN probably would only be able to treat somewhere in the area of 3,500 patients per year from researching the norm for some other companies on the major market in a fairly perfect world. This means that a more conservative number would be as indicated below…
Potential Annual Revenues from probable amount to receive cancer treatment:
3,500 Probable Amount Treated x $93,000 per treatment = $325,500,000
As you can see, this is in line with what some of the major market stocks/companies are generating from the sale of their treatments. Still, the potential is there to make well above that amount when you start considering treatment for prostate cancer and other cancers. There is roughly an 11% profit Margin for stocks within the Biotech Industry as indicated below:
http://biz.yahoo.com/p/515conameu.html
This makes the above amount of ”potential” Revenues from this breast cancer piece to be about $35,805,000 in Revenues for BMSN as derived below:
$325,000,000 x 11% Net Profit Margin = $35,805,000 in Net Profit/Income
Per the recent 8-K below, the BMSN Outstanding Shares (OS) is 1,035,911,549 shares:
http://www.sec.gov/Archives/edgar/data/1079282/000110262413000003/biomatrix8k.htm
Now consider the formulas below to derive a “potential” ”Fundamental Valuation” for BMSN from its breast cancer drug (the HemaXellerate I™ is a different drug and a valuation is explained further below within this post):
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
So…
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
$35,805,000 Net Profit/Income ÷ 1,035,911,549 OS = .0345 Earnings Per Share (EPS)
I will use the P/E Ratio for this breast cancer drug potential that I used in a previous valuation post for BMSN’s HemaXellerate I™ stem cell drug since it is far more conservative than the current P/E Ratio for the Biotech Industry.
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
.0345 EPS x 57.80 P/E Ratio = $1.99 per share
As stated from this news, which confirms the validity of their approach, this gene silencing therapy was developed through over 1.5 million dollars of grant funding at the University of Western Ontario, Canada. This approach offers the possibility of destroying tumors in a non-toxic manner through leveraging the body's own immune system to recognize the cancer as "foreign" and subsequently eradicating it.
http://ih.advfn.com/p.php?pid=nmona&article=56463068
BMSN & the Merk & Co. Connection…
As per Professor Min…
http://ih.advfn.com/p.php?pid=nmona&article=56463068
Quote:
"For more than a decade our laboratory's focus has been to identify how to use gene silencing in the context of immunology. We are enthusiastic to have partnered with Bio-Matrix' Regen BioPharm. We believe this novel approach in treating breast cancer will greatly enhance outcomes for patients," said Professor Min. "While Dendreon's Provenge cancer vaccine has provided an industry precedent for immunotherapy as a practical alternative in oncology, we believe that our approach is capable at competing both at the cost, and efficacy level."
In my opinion, when BMSN added Dr. Wei-Ping Min to their Scientific Advisory Board, it linked BMSN to be in the eyes of Merk & Co. which trades on the NYSE:MRK at $42.00+ per share.
There is absolutely no way Dr. Wei-Ping Min would associate himself with BMSN unless he knew 100% that BMSN had something very worthy of note to be a part of supporting. Because of Dr. Wei-Ping Min’s credentials, if he believes that BMSN is not a scam and is very real, then I will truly trust his due diligence (DD) to do such too.
Dr. Wei-Ping Min is the inventor of siRNA therapeutics which was bought out by Merk & Co for $13.00 per share:
Quote:
http://articles.marketwatch.com/2006-12-28/news/30873760_1_rna-interference-merck-sirna-therapeutics
Sirna Therapeutics holders OK $1.1 bln acquisition by Merck
SAN FRANCISCO (MarketWatch) -- Sirna Therapeutics Inc. said Thursday that its shareholders have approved the company's acquisition by Merck & Co. (US:mrk). In late October, Merck agreed to acquire San Francisco-based Sirna for $13 a share in cash, or $1.1 billion. Sirna develops therapeutics using RNA interference, which aims to treat diseases by disrupting the expression of disease-causing genes. The transaction is expected to close as soon as reasonably practicable, the company said.
Below is confirmation of BMSN making such a move to add Dr. Wei-Ping Min to their Scientific Advisory Board:
Quote:
http://finance.yahoo.com/news/bio-matrix-regen-biopharma-unit-123000524.html
Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.
Here’s a little bit more about Dr. Wei-Ping Min:
http://www.researchgate.net/publication/8440294_RNA_interference_a_potent_tool_for_gene-specific_therapeutics
More About Dr. Weiping Min, M.D.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=85035901
http://regenbiopharma.com/advisory-board.html
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84946297
cowboydancer, with these important BMSN thoughts…
These important BMSN thoughts you have posted are right in line with what I have confirmed from personally speaking with the FDA Office. The info below was taken directly from the FDA website and is what I was personally told by the FDA office…
Guidance for Industry Fast Track Drug Development Programs — Designation, Development, and Application Review
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
On Page 9
On Page 17…
Now everyone should read again an earlier post I made explaining my conversation with the FDA:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84909724
Quote:
InvestorStemCell & All, with BMSN clinical trials...
With what I am about to explain for clarity, please... don't just believe me in what I am saying... please call the FDA Office of Orphan Products Development (OOPD) and ask for yourself. They will confirm that there is a 60 day approval process for drugs that are approved to be an Orphan Drug like I had originally learned from the article of which I had previously reflected within my earlier post.
HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
For clarity... when I created that post, I didn't mean to confuse investors. When I had said... "bypass the lengthy Phase I, II, III, & IV FDA Approval Processes"...
I probably should have clearly stated that instead, there will be some kind of an "accelerated Phase I, II, III, & IV FDA Approval Process" that will be part of BMSN performing some sort of clinical trials.
I was not trying to lead anyone to think that obtaining Orphan Drug Status would automatically permit the side stepping of clinical trials. There has to be some way for BMSN to prove the validity of their drug. When I had personally spoke to the FDA Office of Orphan Products Development (OOPD), I was told that there is a process where there are some clinical trials, but they are accelerated in efforts to try to get the drug out into market with "final" FDA approval within 60 days.
I was also told by the FDA Office of Orphan Products Development (OOPD) that the company will probably have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was not given a time frame, but I was told that the FDA tries to get everything done very quickly.
That "60 day" time frame in my post was originally derived from the link I researched below from my post below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84733882
Quote:
http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
...The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved. ...
v/r
Sterling
This is why I think everyone should also now read all of links again that you posted:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84946297
FDA Small Business Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069906.htm
FDA Investigational New Drug (IND) Application
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
FDA What Is an Orphan Drug?
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107293.htm
FDA Accelerated Approval
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
FDA Fast Track
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84909724
InvestorStemCell & All, with BMSN clinical trials...
With what I am about to explain for clarity, please... don't just believe me in what I am saying... please call the FDA Office of Orphan Products Development (OOPD) and ask for yourself. They will confirm that there is a 60 day approval process for drugs that are approved to be an Orphan Drug like I had originally learned from the article of which I had previously reflected within my earlier post.
HemaXellerate I™ is eligible for Orphan Drug designation where from such, there is a 70% chance that the FDA will give an accelerated approval. Even before then, there is an 85% chance that Investigational New Drug (IND) applications gets approved.
For clarity... when I created that post, I didn't mean to confuse investors. When I had said... "bypass the lengthy Phase I, II, III, & IV FDA Approval Processes"...
I probably should have clearly stated that instead, there will be some kind of an "accelerated Phase I, II, III, & IV FDA Approval Process" that will be part of BMSN performing some sort of clinical trials.
I was not trying to lead anyone to think that obtaining Orphan Drug Status would automatically permit the side stepping of clinical trials. There has to be some way for BMSN to prove the validity of their drug. When I had personally spoke to the FDA Office of Orphan Products Development (OOPD), I was told that there is a process where there are some clinical trials, but they are accelerated in efforts to try to get the drug out into market with "final" FDA approval within 60 days.
I was also told by the FDA Office of Orphan Products Development (OOPD) that the company will probably have to first get IND approval for their drug then it will be sent to their office soon after to be awarded Orphan Drug status. I was not given a time frame, but I was told that the FDA tries to get everything done very quickly.
That "60 day" time frame in my post was originally derived from the link I researched below from my post below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84733882
Quote:
http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
...The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved. ...
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84742689
BMSN**More than “1” Drug Coming IMHO…
In my opinion, I think a second drug as a minimum will also be coming from BMSN. I truly believe that a few other medical occurrences were learned from the previous tests that were done on the BMSN HemaXellerate drug for stem cells. I say this because if you read the PR below, you will see that BMSN is now referring to HemaXellerate as HemaXellerate I™ as if there is now more than one:
http://ih.advfn.com/p.php?pid=nmona&article=56150687
This means that we can presume that there is at least ”two” different types of HemaXellerate drugs that does at least ”two” different things to support the field of medicine. This means that if you consider all of what we all have been believing, we can multiply our thoughts and beliefs by ”two” as a minimum.
v/r
Sterling
BMSN**Why a quick FDA Orphan Drug Approval…
Regen BioPharma, a wholly-owned subsidiary of BMSN, has submitted an Investigational New Drug (IND) Application to the FDA nearly two weeks ago for approval of its HemaXellerate I™ stem cell drug to combat Aplastic Anemia. The post below explains why we should be hearing of FDA Approval for Regen BioPharma/BMSN to move forward with their clinical trials within the next 2 to 2 ½ weeks in my opinion:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84424571
First:
Make no mistake about it that 85% of all IND applications move on to begin clinical trials as can be confirmed from the link below. So I think it is very safe to expect IND FDA Approval from this first round of FDA Approvals as this was mentioned within the link below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83323810
Second (or Next):
Next, because of HemaXellerate I™ being eligible for Orphan Drug designation, there will be around a 70% chance that the FDA will give an accelerated approval to bypass the normal lengthy FDA Approval Process of going through Phases I, II, III, & IV that usually lasts many months and years and grant BMSN this final/full FDA Approval to move forward in as little as 60 days. You will read why I say this later within this post. Below is confirmation from the FDA website that HemaXellerate I™ will be classified as an Orphan Drug because of its use to combat Aplastic Anemia:
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=092695
Quote:
http://www.trainforlifeamerica.com/go/enewsletter/health-conditions?id=45
• Aplastic anemia: This is one of the most serious types of anemia. In this serious illness, the body's bone marrow cannot produce enough of certain blood cells: red, white, or platelets. In about half the cases of aplastic anemia, the cause is never known. The known causes range from a hereditary defect, exposure to radiation or toxic chemicals, or effects of certain drugs. Certain viruses and cancers can be the underlying causes as well.
• Aplastic anemia is a less common type of anemia, affecting about one in every 25,000 people per year. It usually affects those between ages 15 and 24 or those over age 60. Both sexes are equally affected.
• Aplastic anemia – If left untreated, aplastic anemia leads to rapid death.
HemaXellerate I™ is BMSN’s stem cell drug to combat Aplastic Anemia. Aplastic Anemia is eligible for Orphan Drug Status which makes HemaXellerate I™ able to get full FDA approval in as little as 60 days to bypass the lengthy Phase I, II, III, IV FDA Approval Processes because of being eligible for Orphan Drug Status. This is because HemaXellerate I™ has been confirmed to be something special enough to save the lives of people who have been diagnosed with Aplastic Anemia which could lead to rapid death. Read below to learn more about the Orphan Drug Designation:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
Because of HemaXellerate I™ being eligible to obtain Orphan Drug Status, this means the following below can work towards benefiting BMSN and its shareholders:
1**60 days or Less Accelerated final/full FDA Approval.
2**Bypass lengthy Phase I, II, III, IV FDA Approval Processes.
3**The FDA has been offering incentives for developing treatments for rare diseases since 1983, when the Orphan Drug Act became law.
4**The FDA wants to double the number of orphan drug designations that their office approves in the next five to 10 years.
5**The Orphan Drug designation comes with a 50 percent tax credit on any clinical trials that need to be conducted.
6**Drug fees, which currently cost around $1.6 million for one drug application, are eliminated.
7**The company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
8**Major medical companies see “confirmed” future value to be 100% on board and supportive.
9**Dr. Cote says the designation brings the new drug to the attention of investors.
Below is a quote from Dr. Timothy Cote:
Quote:
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens.
The U.S. FDA established the Orphan Drug Act (ODA) in January 1983. For those wondering who is Dr. Timothy Cote, he is the doctor that is over the Office of Orphan Products Development. Read below an important article that highlights the importance of Orphan Drugs which supports BMSN in my opinion with quotes from Dr. Timothy Cote:
Quote:
http://minnesota.publicradio.org/display/web/2010/08/05/orphan-drugs
…The FDA has been offering incentives to companies that develop treatments for rare diseases since 1983, when the Orphan Drug Act became law. …
…The FDA's Dr. Timothy Cote thinks there are many more researchers and companies who could benefit from the orphan drug designation. But he says they're often overwhelmed by the regulatory process.
"We have an opacity problem at the FDA. It's a big black box. Nobody knows what they're thinking inside," said Cote. "And we're smashing that black box. We're making it transparent and we're showing people that what we're doing is reasonable, that we don't bite, and we are just as interested in getting new drugs for people with rare diseases as the sponsors are."
Rare conditions are often described as orphan diseases when there are very few treatment options, largely due to a lack of money for drug research. There are about 7,000 known orphan diseases in the U.S.
Cote, who directs the Office of Orphan Products and Development, says most of those diseases have no approved treatment. For that reason, he wants to double the number of orphan drug designations that his office approves in the next five to 10 years. …
… The designation comes with a 50 percent tax credit on any clinical trials that need to be conducted. Drug fees, which currently cost around $1.6 million for one drug application, are eliminated. And a company that succeeds in getting final FDA approval will be allowed exclusive drug marketing rights for seven years.
But more than that, Cote says the designation brings the new drug to the attention of investors.
"When you get orphan status designation, you go up on our website saying that the FDA has given a nod that this is promising for this rare disease," said Cote. "And then the venture capital rains down from the heavens. That is how it has tended to work for a lot of these companies." …
… The FDA says it will rule on all of the applications it received while in Minneapolis within 60 days. Typically, between 55 percent and 70 percent of orphan drug status applications are approved.
Video of FDA Dr. Timothy Cote - Office of Orphan Products Development:
http://www.youtube.com/watch?v=-sKFl5lAmJE
To further add, I think these posts below by other BMSN investors are very wise to consider too by jjr04001, Zer0Veritas, and T_T23 which helped me to further educate myself on the thoughts I derived above:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84669948
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84670129
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84671685
The poster named jjr04001 is a Pharmacist. So in my opinion, jjr04001 is more qualified than me and your average investor here which lacks any medical qualifications. Much was articulately explained by jjr04001. It was articulately explained how that with HemaXellerate I™ being a treatment for Aplastic Anemia, Aplastic Anemia is a disease which can be described currently as lacking a profit motive because of how rare the disease is and because of how expensive it is to treat. It was articulately explained to look at some of the antiviral treatments for HIV/AIDS (Glaxo's Lexiva - Fosemprenavir) or Genzyme's Fabrazyme (Agalsidase beta) to see how they did not go through 8 years of clinical trials.
Most important in my opinion to note, it was articulately explained that an orphan drug, historically, has an 83% chance of approval to phase II clinical trials, as compared to 33% for non-orphan drugs. Further, Aplastic anemia, if left untreated, WILL kill in 7 months or less. Deaths from this disease are generally quick. "Orphan drug status" is the key here. These drugs are an exception to normal regulatory pre-marketing practices. Treatments for "Orphan diseases" are a guaranteed profit as the patient is a chronic patient, always requiring therapy, payers usually had no problem covering these treatments because of how rare the diseases are, and there are incentives given federally to reduce sales cost and what have you...
Then, it was articulately explained that if you go on the website for national institute of health (NIH) and type in hemaxellerate, you will find a mechanism of the treatment and to then compare this treatment to the current modes of treatment for Aplastic Anemia (Immunosuppression, bone marrow transplant, ATG/ALG, steroids) and compare the side effects/ efficacy / safety and survival rates. Based on the professional judgment of jjr04001 (PharmD.) this treatment has a lot to offer to those who suffer from this debilitating disease (often children).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3543295/
Below is more on the benefits provided for qualifying to be an Orphan Drug:
Quote:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/02/fda-orphan-drug-designations-are-on-the-rise.html
Orphan drug designation qualifies a company for several benefits under the ODA, as amended. These benefits include a 7-year period of orphan drug exclusivity upon product approval (which generally prevents FDA from approving another firm’s version of the “same drug” for the same disease or condition for 7 years), a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.
Again, Federal Grants can be given to support Orphan Drugs as explained below:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
The above is why I truly believe in the post below elaborating why I feel that BMSN has potential to be trading in the $1.19 per share range and possibly sooner than what any of us think:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83394755
v/r
Sterling
I think what some are not seeing just yet with BMSN and its HemaXellerate I™ stem cell drug, is that its competitor drugs,Neupogen®, Neulasta®, Leukine® and Revolade®, are generating over $500 Million in Revenues alone. To understand the magnitude of this, read the DD post below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84424571
To significantly add... HemaXellerate I™delivers an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche of which the other drugs apparently do not deliver such. This is what will make HemaXellerate I™ different and better than those other drugs.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84424571
Why Expect BMSN FDA Approval of IND App...
At times, some people fail to realize that within the penny stock world, it’s not all about where you have been as a company… it’s all about where you are going. BMSN appears to be truly going some places in some major ways.
Per the FDA link below, they will review the Investigational New Drug (IND) application filed with the FDA by BMSN (Regen BioPharma a wholly-owned subsidiary of BMSN) and yes, after not having any comments within 30 days after submission (about 24 now remaining), BMSN could move forward with their goal to initiate clinical trials assessing the company's HemaXellerate I™ stem cell drug in patients:
Quote:
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm
Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
In my opinion, I believe that BMSN will not have any issues because of their TEAM that they have put together to be a part of their Scientific Advisory Board. I’ll further elaborate below.
Below is a post that reflects how BMSN could very easily have some huge Merk & Co. connection since the addition of Dr. Wei-Ping Min to their Scientific Advisory Board:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84165590
Below is a post of BMSN & Cromos Pharma confirmation:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84305036
The CEO of Cromos Pharma is Dr. Vladimir Bogin of which the post below indicates his significant qualifications courtesy of Jobrano:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84415540
Dr. Vladimir Bogin’s comment from the BMSN PR is below along with other key thoughts to add to further affirmation of the advantages of HemaXellerate I™ over other drugs selling within the market:
Quote:
http://ih.advfn.com/p.php?pid=nmona&article=56150687
If the clinical trial is successful, the company plans to expand use of HemaXellerate I™ to other conditions associated with bone marrow dysfunction, with the overall goal of entering the hematopoietic growth factor market. This market is substantial in size and currently includes drugs such as Neupogen®, Neulasta®, Leukine® and Revolade®.
"Current drug-based approaches for healing bone marrow damage involve "flooding" the body with growth factors, which is extremely expensive and causes unintended consequences because of lack of selectivity," said Dr. Vladimir Bogin, CEO of Chromos Pharma (a contract research organization), which collaborated with Regen on filing the IND and member of the Company's Scientific Advisory Board. "Based on our data HemaXellerate I™ possesses the advantage delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche." …
So, to better put this, based on Dr. Vladimir Bogin, the CEO of Cromos Pharma and the rest of the BMSN Scientific Advisory Board, HemaXellerate I™ will be better and outperform Neupogen®, Neulasta®, Leukine® and Revolade® because of delivering an optimized cellular mixture that produces the needed growth factors at the specific location in the bone marrow niche of which the other drugs apparently do not deliver such.
To get an understanding of what this means, read the PR & info below to get an idea of the revenues that are generated from its competitors with a less capable drug:
Quote:
http://www.reuters.com/article/2012/08/29/us-teva-idUSBRE87S1CV20120829
…Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta, the biotech company's longer-lasting white blood cell booster, were $3 billion. …
To add, for inquiring minds, Neupogen® and Neulasta® is owned by Amgen Inc. which trades on the NASDAQ under the ticker of AMGN at $86.00+ per share.
http://www.amgen.com/
Amgen, Inc. (AMGN:NASDAQ) has various collaborative arrangements with Pfizer Inc.; Glaxo Group Limited; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; DaVita Inc.; Fresenius Medical Care North America; Cytokinetics, Inc.; Kirin-Amgen, Inc.; and AstraZeneca Plc.
This is one of many reasons why I truly believe that BMSN will be getting a major Collaboration Agreement for their HemaXellerate I™ stem cell drug from a major Pharma company.
And with Revolade®, which is owned by U.K.-based GlaxoSmithKline PLC which trades under the ticker of GSK on the NYSE at over $45.00+ per share:
Quote:
http://www.advfn.com/nyse/StockNews.asp?stocknews=GSK&article=41953195
Analysts expect the medicine to generate worldwide sales of $260 million in 2012, according to consensus forecasts from Thomson Pharma.
Now read again, the DD previously posted below:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83984795
BMSN Summarized DD to Consider...
Here's some solid BMSN due diligence (DD) in my opinion that I have summarized to hopefully help investors to understand why I feel as confident in BMSN as I do.
http://www.regenbiopharma.com/
Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (OTCBB: BMSN), is a biotechnology company focused on identifying undervalued regenerative medicine applications in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials.
The BMSN/Regen BioPharma Business Model:
http://www.youtube.com/watch?feature=player_embedded&v=0ILddpeLDh8
Bio-Matrix Scientific Group, Inc. Announces Newly Formed Stem Cell Subsidiary -- Regen BioPharma Inc., Secures $20,000,000 in Institutional Funding from Southridge Partners II LP
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-123000672.html
http://www.southridge.com/
http://www.southridge.com/southridge-news-and-events/
Regen BioPharma Unveils Plan for Value Optimization of Nascent Stem Cell Patents
http://finance.yahoo.com/news/bio-matrix-subsidiary-first-class-123000403.html
Month 1-2: Assembly of Team. Completed Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization.
Month 1-4: In-licensing of Intellectual Property. Completed The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development.
Month 3-6: Interaction with Regulatory Agencies. CompletedRegen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials.
Month 6-18: Clinical Implementation. Partly CompletedRegen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy.
Month 18-24: Exit. Currently in ProcessIt is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.
"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."
BMSN Hires J. Christopher Mizer as President and Chief Operating Officer of its Regen BioPharma subsidiary
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-123000923.html
Mr. Mizer is the founder of Vivaris, Ltd., a private investment partnership focused on life science and healthcare opportunities, and co-founder of ChinaBio Capital Partners. He was formerly an investment banker with Key Capital Markets and a consultant with Ernst and Young. He holds a Master of Science degree in biology and an M.B.A. from Case Western Reserve University.
http://www.chinabiollc.com/
We have organized more than 20 conferences in China, the U.S. and Europe, and have generated more than $450M in funding for our participants and clients.
http://www.vivarisltd.com/
We seek companies located across the U.S. with sales between $5.0 million to $50.0 million and an EBITDA of $0.5 million to $10.0 million. We prefer companies that are historically profitable and well managed with well-defined markets, a strong reputation for quality, and a commitment to customer service.
Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in Anticipation of Beginning Clinical Development Stem Cell Studies
http://finance.yahoo.com/news/bio-matrix-regen-biopharma-unit-123000524.html
• World renowned experts to accelerate development of stem cell therapeutics
• Regen anticipates new relationship with Clinartis to fast track clinical studies
Bio-Matrix Scientific Group (BMSN) (BMSN) announced today that its Regen BioPharma unit has appointed three internationally renowned regenerative medicine experts to its Scientific Advisory Board (SAB). The new SAB members appointed are David White, M.D., PhD; Wei-Ping Min, M.D., PhD and Vlad Bogin, M.D.
Regen BioPharma has also entered into a Letter of Intent with Clinartis LLC, a global contract research organization (CRO). Clinartis is a full service global CRO serving pharmaceutical, biotech and medical device companies to support Phase I - IV drug and device clinical trials in the US and Europe.
The SAB and Clinartis will assist the Company in its acquisition of intellectual property related to stem cells, translation of the intellectual property into treatments, and optimizing the value of these new therapies.
http://www.clinartis.com/News.asp
Clinartis has entered into a Letter of Intent with Regen BioPharma, a biotechnology company focused on the development translational medicine platforms for the rapid commercialization of stem cell therapies.
Bio-Matrix Scientific Group's Regen BioPharma Subsidiary Executes Option Agreement to License Stem Cell Intellectual Property
http://finance.yahoo.com/news/bio-matrix-scientific-groups-regen-123000589.html
BMSN’s wholly owned subsidiary Regen BioPharma, Inc. has executed an exclusive option agreement which grants Regen BioPharma an option to license Patent #6,821,513 which patents methods of stimulating blood production in patients with deficient stem cells. The patent, as well as data licensed with the patent, covers methods of stimulating the bone marrow to generate new blood cells.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6,821,513.PN.&OS=PN/6,821,513&RS=PN/6,821,513
Bio-Matrix Scientific Group Announces David Audley, the Founder of International Cellular Medicine Society, Has Joined the Advisory Board of Its Regen BioPharma Subsidiary
http://finance.yahoo.com/news/bio-matrix-scientific-group-announces-183200161.html
http://www.cellmedicinesociety.org/
As executive director and CEO of the International Cellular Medicine Society (ICMS), Mr. Audley has spearheaded development and implementation of global guidelines for accreditation of stem cell clinics. Under his leadership, the ICMS has grown from a loose association of a handful of physicians to a major international standards organization with over 3500 members from 36 countries. He is a strong advocate for stem cell therapy development and implementation, and is the chief architect of the ICMS accreditation program that is currently evaluating the practices of nearly 20 facilities in a dozen countries.
"Mr. Audley has made a substantial impact in the clinical translation of stem cell therapeutics by establishing standards, accreditations, an Institutional Review Board (IRB), and partnerships with major organizations such as the AABB,"
Bio-Matrix Scientific Group, Inc. Recruits Senior Scientist for Its Regen BioPharma Subsidiary
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-123000175.html
Thomas E. Ichim, PhD has joined the management team of its Regen BioPharma, Inc. subsidiary as Chief Scientific Officer and Director of Research.
Dr. Ichim is one of the leading authorities in the world on stem cell biology. To date, he has published 82 peer-reviewed articles and is co-editor of the textbook RNA Interference: From Bench to Clinical Translation.
** He is also inventor on over 30 patents and patent applications.
** He currently serves as the CEO of Medistem, Inc.
http://medisteminc.com/
** Was formerly chief of scientific development, and is the scientific founder / co-founder of Medvax Pharma, ToleroTech, bioRASI, and OncoMune.
http://www.tolerotech.com/
ToleroTech is an emerging siRNA company focusing on treatment of immune-associated diseases through immunomodulation using gene-specific silencing technologies.
http://biorasi.com/site/
bioRASI accelerates the process of obtaining FDA approvals with a full spectrum of services, including:
* Program Optimization
* Project Management
* Regulatory
* Clinical
* Data Management & Analysis
* Compliance & Audit
http://biorasi.com/oncomune
OncoMune develops targeted cancer therapeutics through focusing on a newly-discovered, epigenetic transcription factor called Brother of the Regulator of Imprinted Sites (BORIS). This protein is expressed in all cancers tested to date and coordinates expression of numerous downstream genes that give cancer its properties of immortality, metastasis, and uncontrolled growth.
Bio-Matrix Scientific Group, Inc. Announces Participation in the 2012 Stem Cell Meeting on the Mesa's Investor and Partnering Forum
http://finance.yahoo.com/news/bio-matrix-scientific-group-inc-140000251.html
http://stemcellmeetingonthemesa.com/
Bio-Matrix' Regen BioPharma Initiates Pre-Clinical Study in Support of HemaXellerate(TM) Cell Therapy
Company Also Developing Two Solutions for Restoring Blood Production That Lack the Adverse Effects of Current Bone Marrow Stimulating Growth Factors
http://finance.yahoo.com/news/bio-matrix-regen-biopharma-initiates-133000984.html
BMSN announced today that its wholly owned subsidiary, Regen BioPharma, Inc., has contracted Cascade Life Sciences, Inc. to research the safety and efficacy of Regen's HemaXellerate™ product using mice models for testing.
Quote:
CASCADE LIFESCIENCES
http://www.ohsu.edu/xd/research/techtransfer/startups/2008-ohsu-startup-companies.cfm
The inspiration for Cascade Life sciences grew from the work of OHSU’s Shoukhrat Mitalipov, PhD. Dr. Mitalipov’s laboratory at the Oregon National Primate Research Center (ONPRC) was the first to successfully create monkey embryonic stem cells using a technique known as somatic cell nuclear transfer (SCNT). The technique may advance health care research and discovery and help lead to therapeutic stem cell products to combat numerous human diseases.
Cascade Lifesciences is a privately-owned San Diego-based company with a platform of stem cell related technologies that are being advanced to serve the research community and the commercial development of stem cell-based therapeutics.
…The results of Regen's study will provide the safety profile data required for filing of an Investigational New Drug (IND) application for the product with the US Food and Drug Administration . Regen intends to file an IND Application in the fourth quarter of 2012 and conduct Phase I/II clinical trials during 2013 and 2014.
HemaXellerate™ offers the possibility of delivering a population of endothelial cells to restore blood production in patients with hematological conditions. …
…Regen has submitted two provisional patent applications covering the use of different sources of endothelial cells to heal damaged bone marrow. These applications cover: (1) placental cells (61/648898 - Acceleration 0f Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells); and (2) fat cells (61/670791 - Treatment of Hematopoietic Disorders). …
http://www.regenbiopharma.com/our-approach.html
BMSN SEC Filings:
http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001079282&owner=exclude&count=40&hidefilings=0
http://finance.yahoo.com/q/sec?s=BMSN+SEC+Filings
The below BMSN Fundamental Valuation elaborates as to why I believe that BMSN has the ”potential” to trade in the area $1.19 per share:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83394755
Important for BMSN to trade at the above explained $1.19 per share is for BMSN to maintain being current with their filings on the OTCQB/SEC and if they obtain their FDA Letter. If these things happen, then there are some chances that BMSN ”could” begin heading in that direction over time or even sooner than what some might realize. Still, I like our odds as BMSN shareholders.
To close, below is an example to verify that BMSN trading in the $1.19 per share area is very doable if the company delivers the substance that we all have been expecting:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83431144
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84305036
BMSN & Cromos Pharma Confirmation...
Click on the link below to see confirmation of Cromos Pharma being an active partner of BMSN's recent news of filing an Investigational New Drug (IND) application with the FDA for the stem cell drug HemaXellerate I™ as per Cromos Pharma CEO Dr. Vladimir Bogin.
BMSN’s News with Cromos Pharma of IND application with the FDA:
http://ih.advfn.com/p.php?pid=nmona&article=56150687
Cromos Pharma News with BMSN of IND application with the FDA:
http://cromospharma.com/?id=62
v/r
Sterling
Within the market, there is always a chance for dilution. Let’s not forget that the reason why any stock exists to trade within the market is to use their shares as leverage to raise capital or to provide support to grow the company. Like I have explained before, there is ”good dilution” and ”bad dilution” within the market.
However, any previous dilution done by BMSN has been done to grow the company. This was good dilution. I believe that it is totally foolish to ignore the previous $20,000,000 in Institutional Funding news for BMSN a while back as you can read below which could very easily position all dilution in BMSN to potentially cease:
Quote:
Bio-Matrix Scientific Group, Inc. Announces Newly Formed Stem Cell Subsidiary -- Regen BioPharma Inc., Secures $20,000,000 in Institutional Funding
http://www.regenbiopharma.com/pdf/regen-release-4-30-201.pdf
http://ih.advfn.com/p.php?pid=nmona&article=52208602
Again, as I had previously stated, please, do not use or consider such valuation post to be the gospel for where BMSN is going. Use it as a framework to have in your hip pocket to understand where BMSN could very well go ”just-in-case” BMSN deliver the goods. You will have to use the ”Substitution Property” to replace any variable that may change.
v/r
Sterling
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=83394755
A Very Likely $1.19 BMSN Fundamental Valuation…
Before I explain how ”logically” BMSN could ”Fundamentally” be worth trading in the $1.19 per share area, I think it fair to first understand some of the key variables that I will use to help me to derive this ”Fundamental Valuation” for BMSN.
Look within the Yahoo link below and you will see that BMSN trades within the Biotechnology Industry that exists within the Healthcare Sector:
http://finance.yahoo.com/q/pr?s=bmsn
Within the Biotechnology Industry, stocks that are fully reporting and file with the SEC have a Net Profit Margin % of 11.90% and a Price to Earnings (P/E) Ratio of 57.80 as indicated within the Yahoo Finance database as confirmed below:
http://biz.yahoo.com/p/515conameu.html
Read the post below to fully understand the importance of the P/E Ratio:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57154170
Now consider below that it has been indicated that BMSN is seeking to enter into an $18 billion market for bone marrow stimulating growth factors as indicated below since beginning the development of its first clinical product (HemaXellerate™) which is a cellular drug designed to heal damaged bone marrow:
http://www.prweb.com/releases/2012/10/prweb9972993.htm
The question now is… Do you believe that BMSN would be able to achieve at least 1% of that $18 Billion market if they obtain their FDA Letter? The answers is… Yes, no doubt! However, for the purposes of this valuation, I will remain conservative and figure that BMSN would only be able to achieve obtaining only 1% of that $18 Billion market so that investors could understand the magnitude of the true potential that would then exist in BMSN…
1% of $18,000,000,000 = $180,000,000 in Revenues
$180,000,000 x 11.90% Net Profit Margin = $21,420,000 in Net Profit/Income
Per the recent 8-K below, the BMSN Outstanding Shares (OS) is 1,035,911,549 shares:
http://www.sec.gov/Archives/edgar/data/1079282/000110262413000003/biomatrix8k.htm
Now consider the formulas below to derive a “potential” ”Fundamental Valuation” for BMSN:
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
So…
Net Profit/Income ÷ OS = Earnings Per Share (EPS)
$21,420,000 Net Profit/Income ÷ 1,035,911,549 OS = .0206 Earnings Per Share (EPS)
EPS x Price to Earnings (P/E) Ratio = Expected Price Per Share
.0206 EPS x 57.80 P/E Ratio = $1.19 per share
This means that given the above fundamental variables, the expected price per share could be justified to be trading within the $1.19 per share range for BMSN if BMSN is only able to capture only 1% of its $18 Billion market of which it exists.
If you believe that BMSN would capture still an amount far less than 1% of the $18 Billion market to let’s say maybe ”half” of the 1% of the $18 Billion market, then the expected price per share could be justified trading within the .59 per share range for BMSN.
On the contrary, if you believe that BMSN is going to capture far more than 1% of the $18 Billion market, then for every 1% that you believe it would obtain from the $18 Billion market… then you can ”fundamentally” add $1.19 per share for each 1% of expectation. Example below:
1% of $18 Billion Market = $1.19 per share for BMSN
2% of $18 Billion Market = $2.38 per share for BMSN
3% of $18 Billion Market = $3.57 per share for BMSN
4% of $18 Billion Market = $4.76 per share for BMSN
5% of $18 Billion Market = $5.95 per share for BMSN
And so on… and so on… etc.
With this valuation post, it is like any other valuation post that I have made in that it will not be up to what I post or say in order for these price levels to be achieved. It will be up to the company to deliver the ”substance” that we all here are expecting to be the stimulus for such to transpire. Here with BMSN, that primary substance that should act as the stimulus would be the FDA Letter. If BMSN delivers the FDA Letter to the public, then it is very possible that any of the valuations above by themselves or combined could happen.
Please, do not use or consider this post to be the gospel for where BMSN is going. Use it as a framework to have to understand where BMSN could very well go ”just-in-case” BMSN deliver the goods.
Before closing, there is something else very important to note… BMSN trades on the OTCQB. This means that they are fully reporting and file their financials with the SEC. This also means that they have ”audited” financials already acclimated with its existence.
BMSN SEC Filings:
http://finance.yahoo.com/q/sec?s=BMSN+SEC+Filings
http://www.otcmarkets.com/stock/BMSN/company-info
http://www.otcmarkets.com/companies-advisors/otcqb
Bottom line, obtaining the FDA Letter is key, but of course it will also be important for BMSN to remain current and qualified on the OTCQB venture marketplace too. This means that BMSN is very legit and very transparent. The more investors learn of BMSN and its potential, the more significant growth that will be achieved for BMSN.
With BMSN, there are the following key things that investors are expecting to continue the move northward…
1**Filing of 10Q/K
2**Pending FDA IND Application News
3**Research & Safety Data News
4**Phase I & II Clinical Trial Update News
5**Merger News to bring even more valuation
BMSN Website:
http://www.bmsn.us/
v/r
Sterling
Each stock will do what it will do based on its own merit and not whether or not I post a valuation about it or not. There is absolutely no way you can stereotype the bad in one stock with different managements, different filings, etc. and try to believe that whatever outcome that transpired over there will happen over here with BMSN. To do such is totally foolish.
Since you want to compare BMSN to something, why not compare BMSN to one of the last Biotech stocks that I was in, VKNG, a while ago back when it was at .002 per share:
http://investorshub.advfn.com/boards/memberpoststoboard.aspx?userid=1551&boardid=10896
I "originally" mentioned VKNG at .002 per share (had to get .003 though & higher). Later, VKNG had gone to $1.10 per share. VKNG later stabilized in the .25+ per share area where later VKNG was bought out for .27 per share by CONMED Corporation which trades on the NASDAQ under the ticker CNMD at $28.00+ per share as indicated below:
http://ih.advfn.com/p.php?pid=nmona&article=54279009
My point, which is contrary to yours, is that you just never know as like with VKNG, BMSN do have a history of having ”audited” financials. I am not expecting much from the BMSN upcoming financials, but it is basically nothing more than a formality to maintain being current with their filings with the SEC since BMSN is fully reporting and trade on the OTCQB. I am expecting to see their financials released sometime after the market closes today at the latest.
BMSN is very different than the stocks of which you are referring. I am not saying that BMSN is going to be the next VKNG, but I am saying that you just never know. I do believe that BMSN has more potential than VKNG and since VKNG went to $1.10 without obtaining 1% of its market, BMSN could actually get to such level without ever obtaining that 1% from their market anytime soon. If BMSN obtains their FDA Letter, then the sky will be the limit. This will be when the stars will really begin to align."
v/r
Sterling
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