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Re: None

Friday, 02/04/2022 12:27:49 PM

Friday, February 04, 2022 12:27:49 PM

Post# of 459118
This is the first time I can recall Missling mentioning other regulatory bodies in regard to guidance. Although he was forced to do it, sloppily with grammar errors, I was glad to see Anavex working with them rather closely.

I'm hoping that Missling is planning to apply or already has applied for approval for adult Rett with the UK and Australia, especially when these changes were made with their guidance. Next week Missling will expand on "market access strategy" which hopefully means overseas approval.

Also, what regulatory body gave them permission to change this trial into a phase 3? Obviously it wasn't the FDA. And when changing the wording to pivotal, begs the questions, pivotal to which regulatory body?

All speculation of course.
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