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Re: PlentyParanoid post# 244910

Monday, 10/15/2018 2:12:28 PM

Monday, October 15, 2018 2:12:28 PM

Post# of 403017
Benefits diminish after approval of phase 3. There are still many options for acceleration that apply to phase 3, but need to be addressed during the end-of-phase 2 meeting to be included in a Phase 3 trial design. Again, “ideally” the BTD is submitted before the end-of-Phase 2. For example both OM and UP had one human data prior to the small Phase 2 trials. If a BTD is approved, the FDA is unlikely to require another phase 2 as it would without a BTD, as the FDA is also likely to shorten Phase 3 to a single smaller trial, as it is likely to do with a BTD in place. Still lots of benefits.

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