I give it high odds of success. Meeting primary is really the main thing. Fail that and the secondary end points don't matter.
As we saw with Aduhelm. It doesn't take much to garner approval. Although I suspect the FDA will not be as generous with its approval this time around. They got hammered very badly with the Aduhelm debacle.
The current SOC slows the rate of decline for a short period of time then the decline resumes. If 2-73 can halt the rate of decline for 25% of the people that would be enough to gain approval in my estimation. Anything better than that is a lock.
Missling has sated that he thinks that Anavex can get the voucher. That means that pediatric Rett has to be approved before AD. The only way I can see that happening is if Anavex is doing a rolling submission for Rett. I suppose that Anavex could sit on the AD NDA while the Rett submission is in the works but I think that would create a lot of backlash from investors.
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