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Re: georgesk post# 431306

Monday, 09/18/2023 12:19:39 PM

Monday, September 18, 2023 12:19:39 PM

Post# of 459972
I don't know about that. My brain immediately reverts to the most obvious conclusion that you jumped to -- the data was not statistically significant and Dr. Missling is hiding something.

But then I ask myself, if a trial missed an endpoint after additional analysis and it was previously reported as having met that endpoint, there would be a requirement to file a notice with the SEC because that would certainly be a material event.

And seeing a CEO so blatantly and publicly flaunting the rules just seems unlikely, which makes me question my initial jump to conclusion.

Perhaps it's just a situation where the other endpoint just barely squeaked by and Dr. Jin recommended the alternate pathway toward approval: using stronger data from one primary endpoint and stronger data from a secondary. If his opinion is that the FDA will look more favorably at this, I'm not going to question it.

If the other primary endpoint failed to achieve statistical significance, that is not something the company would be legally allowed to hide. Dr. Missling presented us with the data he plans to present to the FDA. Blarcamesine passed the test for Alzheimer's and it looks like the ongoing extended trial will be sufficient for a confirmatory P3. Rett is on deck. Things aren't as bleak as the stock price might indicate. I mean, SAVA is our biggest competitor and it's down almost as much as Anavex. Did it fail an endpoint, too?
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