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Innovation Pharmaceuticals IPIX
(Total Views: 337)
Posted On: 09/17/2018 2:21:00 PM
Post# of 72447
Posted By: smokenhot
Re: sox0407 #48924
Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained.

IMO The FDA already has the BTD request. End of phase 2 meeting is about what phase3 will look like.













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