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Friday, February 04, 2022 1:04:52 PM
My response to your post is general agreement, but do you think if there is an unmet need for a relatively rare disease without any approved treatment the FDA may be more willing to permit a smaller trial given the drug’s positive safety profile?
Could it approve Rett now on a provisional basis with the pediatric study serving more as a P4-style trial to confirm the data? It seems that if the Rett community applies enough pressure the FDA may cave. We saw with Biogen’s AD drug that the FDA is willing to act outside of the norm when there appears to be a significant unmet need.
Recent AVXL News
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- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
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- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
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- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
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