Rivulet Media Inc (fka RIVU)

[stervc]

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

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

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