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polarbear77

09/20/17 11:25 AM

#120888 RE: Buckboard #120885

I am not an attorney and I don't know the legal answer, however I simply indicated that I did not believe in my gut that the Company could ethically/legally sit on data that was poor or disappointing or worsening from Dec 2016 presentation, and not release it over the last 9 months; while still using the affirmative claims to this date and while still presenting the (positive) Dec 2016 charts in June 2017, etc.

My OPINION was that I didn't think that the SAB/BOD/LEGAL TEAM would collectively advise taking that course by the Company IF TRUE. Would seem illogical and self-injurious.

Again, I do not know the law on that; I simply indicated my guttural opinion.

It was discussed at length back in late July after the Company skipped the AAIC without explanation.

Anyone's guess is as good as mine.

DYODD. Good luck to all longs.

F1ash

09/20/17 11:27 AM

#120889 RE: Buckboard #120885

Someone on here stated that if poor results were known the company legally was forced to reveal them.
Anyone know what the reality is there? Thanks



For most practical purposes, the reality is, they don't have to tell investors about "poor results". If, for instance, patients began dying and the FDA placed a clinical hold on the trial, then the company would have to notify investors in that case.

Otherwise, typically, "poor data" doesn't have to be disseminated until trial completion. As an example, did Anavex notify investors each time a trial participant dropped out?

Gator328

09/20/17 11:47 AM

#120890 RE: Buckboard #120885

This is not true. Sort of. I assume you meant to say if the results are poor, the data must be released in a relatively short period of time from when the company receives those results.

"Poor" is subjective. What one person thinks is poor another might think is terrific. Just look at the discrepancy in the past data releases between shorts and longs and how the data is interpreted.

Moreover, the only time something has to be released immediately is when there is a material impact. So if Anavex were in a Phase 3 trial and the data were bad and the trial was going to end prematurely, or if they received notice from the FDA that the drug was not going to be approved, that is material.

However, Anavex is in the middle of a P2A extension. The data it receives has little bearing on the future of the company and the plans for P3.

The trial is adaptive. Anavex has some data. They also have a regulatory and compliance officer. If Anavex were required to release data, it would have. But they have not, because the company is not required to release the results of interim data that has no material effect on the financial well-being of the company.