Ideally, a Breakthrough Therapy designation reques
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Posted On: 09/17/2018 2:21:00 PM
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.
IMO The FDA already has the BTD request. End of phase 2 meeting is about what phase3 will look like.
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