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I made my initial request, via written submission, to the FDA on or about 03 September 2013. Eight days later I believe it was, I received a phone call from the chief lawyer of the of the FOI division at which time we had an in depth conversation about my request and the protocol. Since I know how the system works, I knew my request would be denied. However, the point was to provide proof that there indeed exists an IND application for HemaXellerate, the amount of time it will take to process a denial (to shed a little light on the amount of time one should expect for them to process an application for human trials) and that whenever the denial is received, credence to the fact that it is still under review (i.e. NOT DENIED) , exists.
The total processing time for the denial from start to finish, was 27 days or thereabouts. The letter is dated 30 September with the envelope being postmarked on 1 October. I am a stones throw from DC/Rockville area compared to most on here. The post was delivered to me yesterday, 03 October.
My disdain for the CEO's actions and inaction remain the same. However, as I have tried to convey a multitude of times, there should be no doubt that the HemaXellerate IND process is very much underway and has had many a challenges, including the Oregon State mishap (no fault of the doctors or reflection on the treatment itself. But, yes, one can argue a failure on the part of the CEO), the trademark name mishap (no fault of the doctors or reflection on the treatment. But, yes, one can argue a failure on the part of the CEO), the medical issues suffered by patients in similar studies that are in no way associated with HemaXellerate that have caused the FDA to see fit to request further preclinical studies and now the gubment shutdown, to name a few.
Thank you. Nice post.
Hi, everyone,
Sorry, not up on all the dd on the board, but has anyone crunched the market potential numbers of their voice recognition system? They do have international protection, right? Any idea what the valuation is based on potential worldwide sales?
I bought in several weeks ago and am surprised by the lack of positive energy with the technology. It has incredible potential IMO.
Thanks in advance.
I concur. Thanks, TPP.
And since I have already noted that I believe the additional data to be about mechanistic details and not anything else, should be about two weeks or so for the data to be generated. At least that is when the data generated will begin to be noted.
Two weeks after injection, animals will be assessed for macroscopic organ changes, and microscopic histology. Organs analyzed will be heart, lung, liver, spleen, kidney and intestine.
A lesson in deductive reasoning (and for those of you that don't know what that means, to cite Wiki): is the process of reasoning from one or more general statements (premises) to reach a logically certain conclusion. Currently in our pipeline we have two products under development, HemaXellerate (a treatment for aplastic anemia) and now dCellVax (a cancer immuno-therapeutic). I believe these two areas represent a solid foundation for our company. Quote: Regen identified the following milestones in the anticipated further development of dCellVax:
Deductive reasoning:
NOW, THAT SAID, to quote this morning's PR:
Does that say "currently we have ONE product in the pipeline"? No, it says they have TWO products in the pipeline. One of which is HemaXellerate.
To quote PG's 18 September post:
Rules 4310(c)(16) and 4320(e)(14) require that, except in unusual circumstances,
Nasdaq issuers disclose promptly to the public through any Regulation FD compliant
method (or combination of methods) of disclosure any material information which would
reasonably be expected to affect the value of their securities or influence investors’
decisions. Nasdaq issuers shall notify Nasdaq of the release of such material information
that involves any of the events set forth below prior to its release to the public. Nasdaq
recommends that Nasdaq issuers provide such notification at least ten minutes before
such release.2
Under unusual circumstances issuers may not be required to make public
disclosure of material events; for example, where it is possible to maintain confidentiality
of those events and immediate public disclosure would prejudice the ability of the
company to pursue its legitimate corporate objectives. However, Nasdaq issuers remain
obligated to disclose this information to Nasdaq upon request pursuant to Rules
4310(c)(15) or 4320(e)(13).
Given what BMSN has had to face with the manipulation, the screw up by Oregon State University and that they have to make some modifications to ensure their patented treatment is 100% PROTECTED by the crooks-at-large (and that includes some BP), they could very well already have approval and have appealed to the SEC to withhold this information while they make certain their property is fully protected.
If it were me, I would certainly appeal to the SEC for with holding this information as the circumstances surrounding so much with this warrant taking every step humanly possible to protect what they have worked so hard to see a reality.
I am liking the constant changes in the Google return for HemaXellerate within the FDA database.
Also, the FDA would allow so much time for the company to address the legal issues before the approval is accessible to the public by way of the FDA database. This is generally established ahead of time. However, there have been extraordinary events that have transpired since the original IND application submission.
A denial however would have to be disclosed within four days. No ifs ands or buts about it. There is nothing about disclosing such that would put the company's objectives in harms way if released. Well, there is obviously. But none that the SEC care about. If there were a denial, we would know within four days.
****The underline is placed by me.
Further, to quote yet again the PR:
a) Generation of human dCellVax: 2 months
b) In vitro demonstration of dCellVax efficacy: 1 month
c) FDA-requested toxicology: 4 months
d) IND submission: 1 month
To me, this says the IND for the dCellVax will be submitted next month. Based on the events and time that have lapsed since the announcement of Min & Benitec. Unless a snag is encountered of course. But, who gives a damn about snags? They are doing it and are GETTING IT DONE!
That is my opinion.
Using deductive reasoning, is it not safe to say that HEMAXELLERATE is a PRODUCT that is soon to see HUMAN TRIALS? Or, very well may be setting up for such now?
BMSN
And an update to the HemXellerate trademark abandonment: the initial application was incorrectly stated as being for HemXellerate--the trademark application was intended to be for HemaXellerate and not HemXellerate therefore the original was abandoned since they were not intending to trademark HemXellerate, rather HemaXellerate.
The trademarking process is proceeding as anticipated.
Anyone wishing to agonize on the phone with the USPTO can confirm this. I just received confirmation a short while ago.
BMSN
The below is from the SEC and though it cites Nasdaq, it seems feasible that such is applicable for any market. Perhaps even more so for the smaller ones that are more vulnerable to manipulation and the corrupt activities of the sharks. If there is an exception, please feel free to let me know. Rules 4310(c)(16) and 4320(e)(14) require that, except in unusual circumstances,
Nasdaq issuers disclose promptly to the public through any Regulation FD compliant
method (or combination of methods) of disclosure any material information which would
reasonably be expected to affect the value of their securities or influence investors’
decisions. Nasdaq issuers shall notify Nasdaq of the release of such material information
that involves any of the events set forth below prior to its release to the public. Nasdaq
recommends that Nasdaq issuers provide such notification at least ten minutes before
such release.2
Under unusual circumstances issuers may not be required to make public
disclosure of material events; for example, where it is possible to maintain confidentiality
of those events and immediate public disclosure would prejudice the ability of the
company to pursue its legitimate corporate objectives. However, Nasdaq issuers remain
obligated to disclose this information to Nasdaq upon request pursuant to Rules
4310(c)(15) or 4320(e)(13).
Given what BMSN has had to face with the manipulation, the screw up by Oregon State University and that they have to make some modifications to ensure their patented treatment is 100% PROTECTED by the crooks-at-large (and that includes some BP), they could very well already have approval and have appealed to the SEC to withhold this information while they make certain their property is fully protected.
If it were me, I would certainly appeal to the SEC for with holding this information as the circumstances surrounding so much with this warrant taking every step humanly possible to protect what they have worked so hard to see a reality.
I am liking the constant changes in the Google return for HemaXellerate within the FDA database.
Also, the FDA would allow so much time for the company to address the legal issues before the approval is accessible to the public by way of the FDA database. This is generally established ahead of time. However, there have been extraordinary events that have transpired since the original IND application submission.
insert-text-here
A denial however would have to be disclosed within four days. No ifs ands or buts about it. There is nothing about disclosing such that would put the company's objectives in harms way if released. Well, there is obviously. But none that the SEC care about. If there were a denial, we would know within four days.
****The underline is placed by me.
NICE FIND, The Popo!
Well, that was my wee 185K that just got added to my lil pot o' gold in SAFC. I am loving the way the stars are aligning for SAFC. Thanks ever so much Frogger for all your dd!
BMSN is not for sale. Koos, from the very beginning however, has made his plan for Regen known. When he intends to execute his plan, only Koos knows. But, there should be no doubt in anyone's mind that Regen is being postured to allow Koos's intended plan be seen come to fruition. That plan involves the exchange of a lot of money from Pharma to the company. For anyone that has researched the market potential based on trends, acquisitions & historical deals, knows full well that the financial potential is rather significant.
This (Koo's execution of stated plan) will be a benefit to shareholders of course. It is my opinion that those who are not holding shares of BMSN when the above mentioned execution takes place, will be very much SOL. Just my opinion based on observation and some songs sung by wee birdies.
(Certain people should just go ahead and do the world a favor and "resign" now).
Oh yeah...there is no such thing as illegal shorting, is there?
My question was whether or not anyone has any updates on the clinical trial. If so, please share.
I am well aware of the differences between Dr. Lewis and David Koos.
Anyone here with any updates on clinical trial: NCT01558908?
I KNOW WHO THE OWNER IS! THE PATENT IS BASED ON A TREATMENT THAT ENCOMPASSES SEVERAL PATENTED PROCESSES. ONE OF WHICH IS OWNED BY OREGON STATE THAT WAS SOLELY LICENSED TO REGEN. HOWEVER, AFTER THE FACT REGEN LEARNED THAT OREGON ALLOWED THE PATENT TO EXPIRE THEREBY ALLOWING PROTECTION TO EXPIRE. ANYONE HAS ACCESS TO IT. WHAT THEY DO NOT HAVE ACCESS TO HOWEVER ARE ALL OF THE PATENTED PROCESSES THAT MAKE HEMXELLERATE. DO SOME READING. GET AN EDUCATION!!!
Good grief! That of course is the case because the patent application was based on information submitted for a patented process obtained by Oregon State University Hospital that was found to be expired after the process had already started. That was Oregon States fault. Not BMSN.
Of course it would have to be abandoned since it would have to be resubmitted with new details.
Big bloody deal. The treatment is the same. But the legalities protecting the name would have to be changed therefore the original application would be abandoned and a new one submitted.
Do you people ever stop with the BS?
With all the information that has been provided on this board, how anyone can sell based on the crap that is constantly spewed by some is amazing to me. Absolutely amazing.
Thank you very much for the kudos.
You summed that up succinctly and with admirable authority.
Further, the shares were not issued to repay for monies that Koos has taken from the company that he then loaned the company. On the contrary--the shares issued were to repay Koos for out-of-pocket expenses. Expenses that far surpass $120,000 as a matter of fact and was personal money. Money that he acquired from other endeavors, unrelated to BMSN. Any personal assets that Koos has gained since the inception of BMSN have not been paid for with shareholder money. The issued shares is a very positive sign IMHO due to the fact that I believe that Koos very much believes in this company and the future it holds. I believe he understands full well the economic promise and therefore believes the stock will rise to such that he will profit handsomely, finally, from his personal and professional investment. As will his shareholders.
It should be noted too that Koos probably has the lowest pay of any CEO in San Diego presently as he accepts the bare minimum monthly as pay. The SEC has all of the documentation to attest to this (the lowest in San Diego is my opinion and subject to debate I do understand).
And to broach something that Seldomehome posted--it is my humble opinion that a CUSIP change could very much happen as certain evidence points to the illegal shorting of the stock by corrupt finance companies with which Koos/BMSN has done business with (silly him. But, trial and error, folk. Trial & error). As far as I can determine, each contract made between he and these finance companies clearly stipulates that shorting of the stock used to satisfy the loans is strictly prohibited. I am no corporate lawyer, but, I have been advised by a couple in-the-know that if pursued, in a court of law, these contracts would be considered null & void if Koos can prove the shorting by these entities. Ergo, if he applies for a change of the CUSIP based on this suspicion, such should be granted.
Of course, it is difficult to prove the shorting by the aforementioned. But, not impossible. And let us not speculate on when this might happen as that will only create more of a frenzy among those that do not quite understand how the process works further adding to the spoils so enjoyed by the sharks.
To date, I have found nothing to indicate that the FDA approval for Hema I is anything but very much in our near future. The preclinical trials for the Min Science is going as anticipated. We should be afforded an FDA application for this, too, in the very near future.
BMSN
Actually, no I have not been quiet. However, as RPH stated, I am limited to one post a day and this is due to the fact that I am not (nor will ever be), quiet.
To address BigCheezies message, I agree wholeheartedly that we shareholders can certainly do with a significant update. Although I wish such would happen asap, if this is not the case, I am not going to quibble about it as I have completed enough research to understand that there is a reason for the madness. I personally would approach it differently. But, that is me. I am not the CEO of Bio-Matrix Scientific Group.
That said, we have been provided a number of updates to keep us abreast of the company's intent and present endeavors. Given that this is science and that their treatments are the wave of the future, there has to be an element of secrecy maintained in order to protect the essence of that they are building. The NIH offers a plethora of scientific journals made available to the public that can offer a great deal of insight into what the good doctors of the company have been and are currently undertaking. To expect them to divulge the inner workings of such monumental dealings would be tantamount to professional suicide.
You wouldn't expect law enforcement to divulge their means of thwarting a criminal act would you? Why would anyone expect a company creating cures for diseases to uncover what they are doing anymore than they absolutely have to?
Does the website need updating? Yes. Is ENTB's public image in dire need of a overhaul? Yes. But, has the company withheld pertinent information to ensure their shareholders are abreast of their plan in motion? Absolutely not.
The latest so-called "dilution" is to satisfy the below, IMO:
BMSN
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 1, 2013
Bio-Matrix Scientific Group, Inc.
(Exact Name of Company as Specified in Charter)
Delaware
0-32201
33-0824714
(State or Other Jurisdiction of
Incorporation)
(Commission File Number)
(IRS Employer Identification
Number)
4700 Spring Street, St 304
La Mesa California, 91942
(Address of Principal Executive Offices, Zip Code)
Company’s telephone number, including area code: (619) 702-1404
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 1.01 Entry into a Material Definitive Agreement
On May 1, 2013 Dr. Wei Ping Min (“Min”) entered into an agreement (“Agreement”) whereby Min assigned to Regen BioPharma Inc. (“Regen”) , a wholly owned subsidiary of Bio-Matrix Scientific Group, Inc.(“the Company”) , all right, title and interest in US Patent # 8,389,708 as well as all Patent applications from the same family corresponding to numbers PCT/CA2006/000984, CA2612200 and EP1898936.(“Min IP”)
US Patent # 8,389,708 was granted to Min with regard to his invention of a method directed to the silencing of immunosuppressive cancer causing genes using short interfering RNA (siRNA) leading to an increase in the immune response, a decrease in tumor-induced immunosuppression and a decrease in in vivo tumor progression.
As consideration for the Min IP, Regen is required to:
(a)
negotiate in good faith with Min with regards to a proposed consulting agreement whereby Min shall perform certain mutually agreed upon tasks for the benefit of Regen for consideration to Min consisting of One Hundred Thousand United States Dollars ($100,000 ) of the common shares of the Company valued as of the date of issuance and to be paid over a twelve month period in twelve equal installments (“Consulting Shares”) and registered under the Securities Act of 1933 on Form S-8.
(b)
Cause to be issued to Min 100,000 of the Company’s preferred shares (“Assignor Preferred Shares”) exchangeable into common shares of the Company (“Exchange Common Shares”) under the following terms and conditions:
(i)
A sufficient number of common shares shall be authorized for issuance by the Company in order that the required number of Exchange Common Shares may be issued
(ii)
Subject to (i) above, upon any date subsequent to the date of the completion of a satisfactory review by the United States Food and Drug Administration (“FDA”) of an Investigational New Drug Application (“IND”) for the Min IP submitted by Regen which shall result in the ability of Regen to lawfully begin clinical testing of the Min IP on human subjects within the United States Min shall be permitted, at his option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.
(iii)
Subject to (i) above, upon any date subsequent to the date that manufacturing procedures for the manufacture of the Min IP have been developed by Regen which comply to the Current Good Manufacturing Practices (“cGMP “) requirements of the Food Drug and Cosmetics Act of 1938 and the rules and regulations promulgated thereunder as they may apply to the manufacture of the Min IP Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.
(iv)
Subject to (i) above, upon any date subsequent to the date that, in connection with a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, both of (1) a clinical trial protocol has been completed and (2) a Principal Investigator has been appointed, Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of Three Hundred Thirty Three Thousand United States Dollars ($333,000) such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.
(c)
Subject to sufficient number of common shares having been authorized for issuance by the Company, Min shall receive, upon successful completion of a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, the results of which (1) shall indicate that the Min IP can be safely tolerated by human subjects (2) shall not indicate that use of the Min IP in human subjects result in side effects of such severity that commencement of a Phase II clinical trial could not occur, and (3) establishes the optimal dosage and/or method of administration( as applicable )of the Min IP , Min shall receive that number of the common shares of BMSN which, at a price per share equal to the closing price of the shares as of the day of issuance, shall equal One Million United States Dollars ($1,000,000)
Pursuant to the Agreement, Min shall be entitled to additional consideration for productivity and deliverables over and above listed items (“”Bonus””). The eligibility of Min to receive a Bonus as well as the nature and amount of any Bonus shall be at the sole discretion and determination of the Chief Executive Officer of the Company.
On June 5, 2013 Regen entered into an agreement with Oregon Health & Science University (“License Agreement”) whereby Oregon Health & Science University (“OHSU”) granted to the Regen an exclusive, worldwide, royalty bearing license to US patent No. 6,821,513 “Method for enhancing hematopoiesis” issued Nov. 23, 2004 (“Patent Rights”) and a non-exclusive, worldwide, royalty bearing license to, among other items, all inventions that are the subject of the invention disclosure giving rise to, or that are described in, patent applications included in the Patent Rights that do not issue into patents. (“Know-How”).
Pursuant to the License Agreement Regen shall be obligated to make the following payments to OHSU:
1. An upfront license issue payment of $35,000 payable 30 days from the effective date of the License Agreement
2. $25,000 on the enrollment of the first patient in a Phase I clinical trial anywhere in the world for each Licensed Product.
3. $150,000 on the enrollment of the first patient in a Phase III clinical trial anywhere in the world for each Licensed Product.
4. $250,000 on the first regulatory approval anywhere in the world for each Licensed Product.
5.The sum of $9,167.12, which represents Patent Costs incurred by OHSU as of April 30, 2012.
Regen shall also be obligated to pay the following royalties to OHSU pursuant to the License Agreement, if executed:
1) 2% Of Net Sales outside the Least Developed Countries; which percentage may be reduced in half where the Licensed Product embodies solely the Know-How and not the Patent Rights.
2) 0% Of Net Sales solely within any of the Least Developed Countries, so long as the Net Sales received by Regen and/or Sublicensees solely cover Regen's or Sublicensees' reasonable and documented direct costs to manufacture the Licensed Products ("Costs").
3) 1% Of Net Sales solely within any of the Least Developed Countries that exceed Costs.
“Least Developed Countries" means each country identified as a low-income economy by the World Bank Group and by the United Nations on their respective websites at the time the Licensed Product is transferred, and all other countries mutually agreed to in writing by OHSU and Regen. Net Sales" means the gross invoiced amount, and/or the monetary equivalent of any other consideration actually received by Regen and/or its Sublicensees, for the transfer of a Licensed Product, less certain expenses.
Commencing on the first January 1 to occur after the first Net Sale, and for each year thereafter, Regen will pay to OHSU minimum annual royalty of Ten Thousand Dollars (“Minimum Royalty”). Minimum Royalties will be credited against any subsequent royalty payments made by Regen, but only for the year in which the Minimum Royalty was received.
The License Agreement shall also require Regen to:
(a) Pay OHSU a license maintenance payment of $1,000 by each anniversary of the effective date of the License Agreement for the first four years until the first Net Sale and a license maintenance payment of $5,000 by each anniversary of the effective date of the License Agreement beginning in year 5 until the first Net Sale
(b) Pay a percentage of all remuneration received by Regen from a Technology Sublicensee (any person or entity that directly or indirectly obtains any rights in or to the licensed technology from Regen to use the licensed technology to further develop or modify the licensed technology or to incorporate the licensed technology into such Technology Sublicensee’s products or services) whether in the form of money, equipment, property, equity, debt financing or any other cash or noncash consideration, other than sales generating royalty payments to OHSU
(c) Reimburse OHSU for all out-of-pocket costs and expenses incurred by OHSU in connection with the preparation, filing, prosecution, defense, including interference and opposition proceedings, and maintenance of the Patent Rights.
Item 9.01 Financial Statements and Exhibits.
EXHIBIT INDEX
Ex.10.1 WORLDWIDE INTELLECTUAL PROPERTY ASSIGNMENT AGREEMENT
DATED May 1, 2013
Ex.10.2 LICENSE AGREEMENT
DATED June 5, 2013
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
BIO-MATRIX SCIENTIFIC GROUP, INC.
By: /s/ David Koos
David Koos
Chief Executive Officer
Dated: June 11, 2013
Thanks folks...Inventor and I have picked up more than 2 milly today. We certainly appreciate it!!!!!
BMSN
We have a little bit before an IND number for the MIN science. Mind you, since preclinical trials have been moving along as anticipated (if not better), the FDA application for the MIN science could be submitted earlier than originally expected, I suppose. Who knows?
With regard to the first two, I think you very well might be on to something. And wouldn't that be just so very delightful?!?
Wouldn't it be nice to see a Cusip number change coupled with FDA approval of Hemaxellerate and Min ind number? Scenarios scenarios.
Your Pluristem references are wrong! Simple as that--your points are moot; your time references are erroneous; the details of the filings are not noted; the fact that this science uses placental cells and not patient derived cells (big difference) is not highlighted; that the company's experience in governmental filings far surpasses that of BMSN filings (therefore they are familiar with what is needed for submission by way of repeated trial & error); that the FDA HAS been working to make changes in how the process for Orphan Drug status is established; that 75% of stem cell therapy NOW consists of patient derived cells and that this is relatively new and requires constant updating within the governmental agencies that are charged with overseeing patient safety.
You are disseminating misinformation. No ifs ands or buts about it.
The HemXellerate line is NOT the same as the Min Science and the Benitec science. Two entirely different treatments and approaches.
The FDA as well as many other governmental agencies around the world are working to make the necessary changes in order to allow stem cell therapy and gene silencing treatments be considered and ultimately APPROVED more efficiently. The FDA is actually considered archaic by some governments with respect to the way they approach new sciences. This can be found in many publications by various foundations and organizations all over the world.
Links to the aforementioned have been provided by me time & time again.
TRY DOING SOME SERIOUS READING!
www.pluristem.com/press-releases/
https://www.federalregister.gov/articles/2013/06/12/2013-13930/orphan-drug-regulations" rel="nofollow" target="_blank" >https://www.federalregister.gov/articles/2013/06/12/2013-13930/orphan-drug-regulations
http://www.blog.aynrandcenter.org/fda-versus-stem-cell-therapies/" rel="nofollow" target="_blank" >http://www.blog.aynrandcenter.org/fda-versus-stem-cell-therapies/
www.opp.sagepub.com/content/early/2013/02/25/1078155212472702.abstract
www.evaluategroup.com/Universal/View.aspx?type=Report&id={8C80816D-658A-4085-BA10-B579001800B0}¶ms=%3CPARAMS%20currencyId=%220%22%3E%3CPARAM%20linkKind=%221%22%20name=%22regenerative%22%20/%3E%3C/PARAMS%3E&more=true
http://www.marketresearch.com/search/results.asp?categoryid=0&query=Bio-matrix+scientific" rel="nofollow" target="_blank" >http://www.marketresearch.com/search/results.asp?categoryid=0&query=Bio-matrix+scientific
http://www.marketresearch.com/search/results.asp?categoryid=0&query=Regen+Biopharma" rel="nofollow" target="_blank" >http://www.marketresearch.com/search/results.asp?categoryid=0&query=Regen+Biopharma
I COULD GO ON AND ON AND ON AND ON!
BMSN
Fantastic, PoPo! Fantastic.
Further to that, there are subsets and contingencies that are applicable on a case by case with the FDA.
As I have maintained, I believe when the news of approval hits, announcement of Orphan Drug status will be announced as well. No crystal ball of course but that is my educated WAG.
In consideration of the way the FDA process works, the rapid changes to the process that are being implemented, coupled with the fact that the company have provided all efficacy & safety data, we can be awestruck anytime now.
There is a bang coming. A very big bang!
BMSN
Actually, that is not entirely true. Granted, when the company receives the final FDA response, such has to be announced within four days I think it is. Might be three.
However, if there are physical inspections required and scheduled, or conferences with physicians, or physical verification of signatures to documents, etc., etc., required by the FDA in order to complete a process or allow for the approval and such must be rescheduled due to medical emergencies that have arisen with a key member of the process, this does not have to be conveyed publicly/disclosed.
Further, if a new FDA application is in the works and required signatures that could not be obtained due to a medical emergency that caused a delay in the required persons meeting for such signatures, this would not be conveyed/disclosed.
When such matters are at last addressed and finalized, this is considered material and is released to the public.
The above are by no means anomalies.
That said, the next PR is either going to be a reiteration of what we already know is presently happening (I would like to think not as the company is well aware of shareholder sentiment about what is being considered "fluff" PR's) and that is a great deal whether many want to embrace this or not. OR we are going to be informed that the company has initiated something new and/or has a FDA decision on HemaXellerate.
Professor, I think you might be on to something there.
The science is there. All this information is public. You just have to dig for it.
I have to do a bit more research on the data I have located before speculating on that. But, given that the trademark application for HEM should be completed any day (I am thinking there is some connection). So, Christmas is not out of the question. But, I am still looking.
Sometimes it seems clear as mud, I do understand that. You are very welcome.
One more thing I will address or tiptoe around...HEMA I...Orphan Drug Status--I am 99.9% confident that yes, it will be approved and have orphan drug status.
Hema II: Same thing; IND will be applied for using the same therapy, treating a different disease. I am 99.9% convinced Orphan Drug status for this as well.
You're welcome and thank you. That is the best I can do presently.
Let's see, how to say this without getting on Dr. Koos's bad side...
Upon my arrival, a key member of the company was detained elsewhere due to a family medical emergency that quite literally occurred as I was en route to San Diego (no, wasn't BS, situation confirmed, happened as it was conveyed to us). This key member of the company was scheduled to attend a conference with/for the company to tie up some loose ends. These loose ends were key to the release of the PR that Dr. Koos indicated we should expect by weeks end.
Since I did confirm days after my return from San Diego that the medical/family emergency was still very much present, I can only surmise that this created a delay in what was planned to be executed last week thereby delaying the PR.
I don't doubt for one moment that what was scheduled to take place will or perhaps already has very, very recently, taken place. When it does, we will get that PR.
I hope this helps.
Thank you.
WEEEELLLLLLLLLLLLLLLLLLLLLLLL, actually, Sabai, since Dr. Ichim is the CSO and HE applies for and EXECUTES the patents AND the sciences are based on his work AND he is the party responsible for providing the required FDA information, if it fails, YES, he is responsible.
Next point?
Maybe they can swap BBQ recipes!
Enlighten us, Sabai...how long does it typically take? Please tell us, how long does it typically take for the FDA to receive, evaluate, consider and approve or disapprove and IND application? Particularly one using a relatively approach?
PLEASE, impart your wisdom on FDA procedures with respect to this.
THAT IS BULL$HIT!
LOL, DK.
Hey! Don't shoot the messenger! It's all relative!!!
Specialized Enforcement Units
At the beginning of 2010, the SEC’s Division of Enforcement announced the creation of
five specialized units designed to focus on complex subject areas of particular interest to
the SEC. One of those specialized units, Asset Management, is dedicated to
enforcement matters relating to registered and unregistered investment advisers,
including advisers to private funds.2
The division also created a new Office of Market
Intelligence, led by Thomas A. Sporkin, that is responsible for “the collection, analysis,
risk-weighing, triage, referral, and monitoring of the extraordinary number of tips,
complaints, and referrals the SEC receives each year.”3
The Asset Management Unit is led by Co-Chiefs Bruce Karpati and Robert B. Kaplan,
two associate directors within the Division of Enforcement, and has been fully staffed
since the spring of 2010. It consists of approximately a dozen assistant directors in the
SEC’s home office in Washington, D.C. and nine other regional offices, and individual
staff attorneys in each of those locations. The members of the unit reportedly hold regular
meetings to share market intelligence, develop investigative leads, and discuss particular
theories of liability.
Although the jury is still out on the effectiveness of this new structure, the theory behind
the new units—that Division of Enforcement attorneys dedicated to particular areas will
be more effective in combating violations of the federal securities laws—is a sound one.
As the attorneys in these units become more familiar with the private fund industry,
advisers who find themselves subject to SEC scrutiny should expect investigations to
proceed more expediently and with greater focus.
THE ONLY GOOD THING THAT CAME OUT OF BMSN BEING ILLEGALLY TRADED ON THE BOERSE IS THAT THE ILLEGAL ACTIVITY AND THE COMPANY'S INNOCENCE IN THIS CAPTURED THE ATTENTION OF THE AUTHORITIES. That coupled with the fact that some folk just love to talk about how they make their ill gotten gains off working a stock is proving most interesting to some powers-the-be.
Long & strong BMSN. Patiently waiting.
Because of the rampant manipulation, shorting & death spirals created by various entities for some penny stocks (and that includes when they are sub penny) FINRA does look at individual companies and are working in concert to thwart the corruption in the best interest of the companies and the shareholders.
And this especially includes companies that were listed to foreign exchanges without permission or knowledge of the company. As with the case of BMSN and the Boerse.
There are several avenues that these crooks take. All are under scrutiny now.
Just the way medicine is rapidly changing, so is the way the Untied States is policing and handling the corruption within the penny trading market.
BMSN
Now wouldn't that be awesome!
BMSN!
And this doesn't cover the manipulation by other entities. A lot of crap out there this company (and many other legitimate companies as well) has had to combat.
It does have to end, though. Thank goodness!
BMSN
DIRECTLY FROM FINRA:
Pursuant to a Securities and Exchange Commission request, FINRA has agreed to make reported short sale trade data publicly available
(Click that link there above and check in ORF. YOU'LL SEE BMSN!!!!!)
There is a reason illegal activities are referred to as corruption... Because, well, it is illegal. Doesn't stop people from doing it.
And as I have said, it won't last forever.
LONG & STRONG
It is a fact that to evoke high-arousal emotions (anger, fear, awe) is the most viral type. When such emotion is evoked, people react precipitously, oft times willing to take a loss if a fear of losing all is instilled. More often than not, there is no verifiable or empirical evidence to validate their accusations but at the same time, few work to counter their falsities because the gains don't appear commensurate the required work.
This business is cutthroat and only the strong survive, really. Few are willing to offer a counter to their approach. So, if these people scare the bejeezus out of folk with their false information and you sell, their work is done and they make out like a fat cat.
If a company mucks up, OK, bring it to light. But, make sure the muck up is that and only that. And not a means to a successful end. Otherwise, all else is mudslinging and playing on fear and ignorance for gain.
Always read the post history and use your own brain power to determine whether or not your receipt of their input will benefit you or them. Then go with what you know.
BMSN.
With respect to my agenda (and haven't a clue what was accused), I could have long ago kept quiet, continued to dig and continue to accumulate. As frustrating as it is to see the massive walls put before us, I know why they are there and that with what this company has, it is only a matter of time before a.) those that manipulate will be stopped in their tacks and B.) Big money will jump in for they DO want what Regen Biopharma has. I know this as well as I know the science and the bureaucracy.
If I had any agenda contrary to anything other than assisting fellow investors and seeing a wrong righted, I would have been long gone from this place. I know how this business works. We wee fish are not going to make the incredible difference here; the big fella's are. I am patiently awaiting their arrival (and it is nearing). Just as many of the good people I have met along the way on here.
BMSN
I'll have to look that up.