Rivulet Media Inc (fka RIVU)

[Canadian Trader]

It's not hard, Beek; just a bit of googling and browsing the FDA website. Here you go:

Page 53:
"FDA shall provide a written determination 30 days after FDA receives the IND or earlier" This goes for their subsequent replies as well.

Page 61:
"Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days." This means that any time BMSN/Regen wish to update their IND, they can only do so every 30 days. That's why it is likely that we could be inside yet another 30-day window right now and not know it.

Page 69:
"The clinical hold order will be made by or on behalf of the Division Director with responsibility for review of the IND. As soon as possible, and no more than 30 days after imposition of the clinical hold, the Division Director will provide the sponsor a written explanation of the basis for the hold."

REFERENCE: PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
http://www.gpo.gov/fdsys/pkg/CFR-2003-title21-vol5/pdf/CFR-2003-title21-vol5-part312.pdf

Here's the main directory with links to information on the FDA IND process. If you find anything interesting please share with the board.

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

One thing I haven't found is a statement that the company needs to report bad news (i.e., FDA denial) within 4-5 days. That is something I have only seen on the board. I suspect that will not be found within the FDA site and may be more of a regulatory thing for the stock. Anyone with information on that please post.

Cheers,
Canadian Trader