I agree M. If Prana received a partial clinical hold on the 250 mg dose of PBT2 with the safety record that Prana has I can only imagine what FDA will do when reviewing the 6 or 10 mg dose of the BIIB drug.
This is something I have been wondering about. Biogen claims, on the heels of their release of the 6 mg dose data, that they are recruiting for their Phase 3 already yet there is no release or mention anywhere of the results of the End of Phase 2 meeting with FDA which I would think that even though they are skipping Phase 2 there would be some sort of pre-Phase 3 meeting. I wonder if they have discussed this with FDA yet and I seriously doubt a 6 mg dose will be allowed in a Phase 3 trial since last week's results were issued. The 3 mg dose showed no functional benefit.
Here's the EOP2 meeting info from 21CFR 312.47:
(1) End-of-Phase 2 meetings --(i) Purpose. The purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for the uses under investigation.
and,
"(v) Conduct of meeting. Arrangements for an end-of-Phase 2 meeting are to be made with the division in FDA's Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research which is responsible for review of the IND." ... "The meeting should be directed primarily at establishing agreement between FDA and the sponsor of the overall plan for Phase 3 and the objectives and design of particular studies. The adequacy of the technical information to support Phase 3 studies and/or a marketing application may also be discussed... Barring a significant scientific development that requires otherwise, studies conducted in accordance with the agreement shall be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval for the drug."
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