Replies to post #91841 on Rivulet Media Inc (fka RIVU)

[RPH9878]

I do not believe the 30 day responses applies after Q/A is in effect. Also we do not know when BMSN responded or when the FDA received the response.

[PG]

That is an incorrect assumption-- the "30 days" is a no news is good news rule during the initial 30 days of application submission. Since most companies--especially newbies in the world of IND submissions--encounter some form of Q&A during the process, the amount of time required to complete the Q&A is the amount of time required to complete the Q&A. Since it was roughly 30 days for the FDA to return with the first set of questions and roughly 30 days to return with noted satisfaction of answers to said questions but a requested data updated on efficacy, the consensus is that it will be roughly 30 days for them to return their response to the efficacy data.

BMSN