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Tuesday, July 21, 2020 3:06:21 PM
“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.
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