Replies to post #2224 on Revive Therapeutics Ltd (RVVTF)

[Bruinfan4ever]

FDA is working overtime. And we don't know how many applications are ahead of Revive. Who knows if they go in order or not.

I wouldn't assume anything right now. It's not normal times.

[Beatcovid]

Go to FDA web site on IND applications. They say it is "Rare" to get turned down. That they work with the company and send them on their way to trials....all we have is facts. The FDA had them skip phase 2 and apply for phase 3

[tendies]

FDA not responding is a good thing.

“The IND becomes effective 30 days after the stated FDA receipt date unless the FDA sends notification otherwise. The FDA generally does not send a letter notifying the sponsor-investigator of approval. Studies may begin after the 30-day interval, if the FDA does not notify the investigator otherwise.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4435682/#S10title


So we basically have the green light folks. FDA gave us the green light to skip phase 1/2 and go right to 3. The 30days from IND application is just so they can do a final review. If revive hears nothing, then it’s smooth sailing right to phase 3.