Agreed, Investor is correct, and this is an excellent strategy chosen by Anavex and explained by investor. This is what Missling was trying to convey in the last CC, although not so artfully. Here is some of what he said to not so artfully convey the strategy:
"...The next question is, will the AD NDA be submitted before the confirmatory trial is completed? The answer is after discussion with the agency for Accelerated Approval Pathway, this would be the path which was also given to the other accelerated approval company approvals (my insert: Lecanemab for example). So this could be the case as well. Otherwise, it would be not accelerated approval if you need a study to begin with. So that is the goal of getting the drug approved before completing a confirmatory second trial....
.....Again, a confirmatory study is needed after accelerated approval. And so that is regarding the additional study, but it's not required for accelerated approval for approval of the drug for the Alzheimer's study....."
I am bullish Anavex, and I am pleased with this strategy Anavex is pursuing. It is a very wise strategy. I think some posters here are thinking that if you label the “confirmatory trial a Phase 3, Anavex is precluded from obtaining AA, which is simply not the case. So, relax and enjoy the rest of your weekend. One of these days, we will know all we need to know, but I would never bet on when that may be. Keep your expectations low on when that day will come, and you will lower your stress level (your cortisol level will drop precipitously!).
[If Anavex do achieve AA, there will then already be a P3 trial running that may later be the basis for traditional approval and no P4 trial required] you timing is inaccurate,...with as you say 2 to 3 years if P3 just starts soon, then any AA soon will revert P3 to a P4 which 99% of the time will be OL ie placebos get drug, not waste away for 3 additional years
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