RE:RE:RE:RE:Back to the MGH/DrG announcementI totally agree with mr. Wino115!
That was my understanding too when i talked to mr. T. in december. The
FDA is not waiting 8 months to give an answer, but the whole proces
(questions/answers) could eventualy take that time, therefore he said end
of 1H !!
Hope to get some clarifications when talking to him again (somewhere
next week).
In the meantime, down down......:-(
Wino115 - (2/10/2020 9:58:27 AM) RE:RE:RE:Back to the MGH/DrG announcement Yes, is my guess. I think there is probably some gray area in relation to what is considered material for a proposed FDA meeting. As was shown with Spectral down below in a message, they felt that just having the meeting and getting feedback was material. Others may wait until the actual next step is needed, so having the meeting, reviewing the suggestions, answering the lingering questions and re-proposing the trial steps with the suggstions or counter-proposals and getting the actual OK. Then they announce the FDA consultation is over. You could probably argue both sides. Knowing THTX, they'll wait for the actual endpoint so it can be fully buttoned up with no questions asked. I can understand that. Just announcing they had the meeting would mean millions of questions on what the comments were, etc.. Until those are all answered you would leave the market with even more uncertainty and questions. It really wouldn't help I don't think.
To come out once done with the full FDA discussions and say 1) We have taken all FDA suggestions on board. 2) Here's out trial design - size, time, cost estimate 3) Here's what we want to prove for both NAFLD and for NASH. Then it's fully nailed down. They'd have to do the same with EMA. They probably won't know full cost until EMA also agrees, so you may not get that estimate until the very end. But size-wise, I can't see them asking for a huge sample given the massively smaller universe as the starting point. 300-400 should provided statisticallly meaningful results even with the normal drop-outs and placebo sleeve.
But I guess my point is there is a wide interpretation of what legally needs to be announced as material. Some things are very clearly 100% material, some you can wait for clarification and finality. That's what they're doing.