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Re: infitvest post# 306281

Thursday, 04/08/2021 6:10:15 PM

Thursday, April 08, 2021 6:10:15 PM

Post# of 463375
Another factor that is being overlooked in the discussion is that actigraphy data has no standards for interpretation.

That means that however Anavex chooses to interpret the data there will be criticisms. Not to mention how that will slow down the peer review process.

Anavex has to be very careful about what conclusions they draw from that actigraphy data.

I keep wondering about where Anavex is in the process of the FDA meeting that theoretically was requested back at the beginning of the year. I contacted IR on the subject and was told that the company would not comment on whether the meeting was scheduled or not or when it was scheduled. I was told that the company would most likely put out a PR when the results of the meeting are known. As I understand the rules the FDA has to respond to a meeting request in 60 days. That means that a date for the meeting has to be given in 60 days. I couldn't find anything in the rules that said how limited far in the future that date could be.

Depending on what the outcome of the FDA meeting is, it could have a significant impact or a minor impact on the share price.

Maybe that is a reason for there not being much information from the company. Depending on the results of the FDA meeting, the way forward could take a number of different paths. All of which will make different choices available to the company.



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