Rivulet Media Inc (fka RIVU)

[stervc]

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

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