Replies to post #303057 on Anavex Life Sciences Corp (AVXL)

[Doc328]

I feel that the 2b/3 could be a pivotal study but that 2 pivotal AD trials will be necessary for approval

Missling was actually cautionary in his choice of words about the likelihood that FDA might consider A273 for approval based on one study. I don't think the likelihood is 0% but rather in the 5% range. Hence my comments and prediction for the need to do another phase 3 and why SAVA is not actually behind in AD. If my 95% likelihood of an additional trial becomes 100% reality, and the second trial dies not start until after results from the first trial, then AVXL is actually behind in the timeline. Of course AVXL has Rett and as a true orphan indication, there is a possibility of approval after Excellence if results are stellar.

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.

[TempePhil]

Remember Dr.Fadiran worked for the FDA for 24years, and is advising Dr.Missling on FDA affairs.
While I have not been happy with the apparent additional enrollments(versus published clinicaltrials.gov numbers), and longer schedules, it may be that this is due to Dr.Fadiran's advice... maybe to help solidify the phase 3 data acceptance for approvals.