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nidan7500

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nidan7500

Re: Amatuer17 post# 137206

Saturday, 01/13/2018 8:04:26 AM

Saturday, January 13, 2018 8:04:26 AM

Post# of 462088
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM592001.pdf...

Check out pg 13. The new rules are written to allow discretionary authority to FDA when interim trial results warrant such. Very cool. IMO.


Completely agree - with so many AD drugs failing FDA will not take risk of approving anything on limited data/results. They will definitely ask at least one P3 - so co as well may do a very good P2b

In any case we are looking at 2-3-4 year journey
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