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Re: Gernee20 post# 347044

Friday, 01/28/2022 1:27:04 AM

Friday, January 28, 2022 1:27:04 AM

Post# of 457761
Gernee, That thought crossed my mind. I considered this scenario.

The TLD data for Avatar looks good. Anavex takes it to the FDA and the FDA says it looks very good lets make this trial a P3. There are no SAEs. Maybe you should consider an interim look at Excellence.

The timing on this is not quite right for me. But having said that you have to wonder why the increase in subject numbers? What information was available that caused the FDA to suggest an increase? Was it just the DSRB review that said continue with the trial since there are no SAEs?

The increase in subjects was explained as needed to allow some age grouping for data analysis. I vaguely remember something about a group of 5 to 12 and 12 to 18. If anyone has the information on that I'd appreciate it. I thought that age grouping was interesting since much development is done by age 12 in girls. Girls seem to physically mature sooner than boys.


There are some pieces missing in this puzzle.

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