Rivulet Media Inc (fka RIVU)

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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

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:

"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:

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:

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