Revive Therapeutics Ltd (RVVTF)

[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.