hnbadger, I did not post that info on ST, but I was there and I would agree, in the main, to what the poster said.
1. As to the peer reviewed paper, he did say it would very likely be published before the MAA is submitted (although he did take care to say that they were completely independent events.)
2. My understanding of what he said (and it was slipped in quickly) was that the MAA wouldn't be submitted before September. This is no surprise given what I have been saying about the submission request for rapporteur assignment. It was apparently made before the February 7th submission deadline, and at that point the EMA was therefore being told that it was projected to be filed between late August and early September. They have had the opportunity to amend the filing date since then. What he did specifically say in the presentation is what he has said publicly before, "It will definitely be filed this year."
3. As to Schizophrenia, yes, he did say they were beyond the first cohort and I also understood that the second cohort was being dosed now. That does mean that Part B should be coming up fairly soon after that data is analyzed. In answer to my question Missling said that it was quite possible that the study could be finished before the end of the year.
4. In answer to another trial question he did reiterate what he said on the last call - i.e., that the PD trial would start this year. As to Rett, he suggested that we would hear more about their plans at the Rett conference where they are presenting (this week?).
5. He did make some more remarks on autophagy as a key component of the MOA. (Personally, I believe as the story of our drug comes out, this autophagy angle will provide a good bit of extra sizzle.)
6. Yes, he did say that they have had no formal meetings with the FDA since the end of the AD trial (although it wouldn't surprise me if there had been some back channel communications). As he has said before, he plans to go to them when he has the OLE data/analysis and after he has filed the MAA. He did also say that the doesn't believe there is a need to wait on filing before the new FDA guidance on AD is fully approved and in the Federal Register. He showed a fair bit of confidence by saying that under the new guidance "the study should be fully approvable."
