Replies to post #306287 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

If Missling said that I missed it. Could you tell me which meeting that was in please?

[bb8675309]

Steady_T - It was last quarters earnings call 2/11/21

This is what I thought was our meeting on June 7th. I work long hours.

Christopher Missling -- President and Chief Executive Officer

Obviously, I cannot predict what will happen on June 7th when the meeting from the FDA will take place to decide about Adu. But I would say that if it turns out positive, and that is a scenario you referred to, it would actually mean that the FDA would agree that one robust clinical study would be sufficient to approve a drug in Alzheimer's disease. And since we are running now a robust Phase 2b/3 study as well, this could be a positive for us in that regard. If the decision on the 7th of June is more negative in outcome, then it would still not, I believe will not in way or shape impaired because we are basically, by that time, advanced with our study and there's also ability for supportive data from the Phase 2a with our Phase 2b/3 study.

So we just put our heads down and move ahead, but I would think that it's possible that there will be positive resonance if the study would be approved -- the other study would be approved mid of the year.


https://www.fool.com/earnings/call-transcripts/2021/02/11/anavex-life-sciences-avxl-q1-2021-earnings-call-tr/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article

[attilathehunt]

"I believe it was also mentioned that BIIB meets with the FDA on June 7th for aducanab or whatever its called. "


That's when I expect to hear from TGD...He will wait until after the FDA meeting with BIIB, to make results known. Missling wants eyes on Anavex.

[Doc328]

June 7th is the PDUFA date for aducanumab (ADU), not a meeting. That's the self imposed deadline for the FDA to have a decision, denial or CRL, They can also defer to a later date. In the convoluted answer that Missling gave to the question, he is stating that the only way that the FDA approves ADU will be if they focus only on the one large positive phase 3 and ignore the other negative phase 3 study which was negative. If that occurs, he implies that that outcome is good for Anavex because, in Missling's opinion, Anavex is running a 'robust 2b/3' now and therefore maybe they could submit to the FDA with only one study. He then pauses to place his rose colored sunglasses on to say that even if the FDA says adieu to ADU that maybe they could submit to the FDA with one positive study anyhow because of the 2a.

Christopher Missling -- President and Chief Executive Officer

Obviously, I cannot predict what will happen on June 7th when the meeting from the FDA will take place to decide about Adu. But I would say that if it turns out positive, and that is a scenario you referred to, it would actually mean that the FDA would agree that one robust clinical study would be sufficient to approve a drug in Alzheimer's disease. And since we are running now a robust Phase 2b/3 study as well, this could be a positive for us in that regard. If the decision on the 7th of June is more negative in outcome, then it would still not, I believe will not in way or shape impaired because we are basically, by that time, advanced with our study and there's also ability for supportive data from the Phase 2a with our Phase 2b/3 study.

So we just put our heads down and move ahead, but I would think that it's possible that there will be positive resonance if the study would be approved -- the other study would be approved mid of the year.