Food for Thought: The AMX0035 (Albrioza) Situation | CORT Message Board Posts


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Msg  4202 of 4637  at  9/21/2022 2:36:35 AM  by

BSR_Alan

The following message was updated on 9/21/2022 2:57:42 AM.

 In response to msg 4198 by  bubbarayjr
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Re: Food for Thought: The AMX0035 (Albrioza) Situation

We will hear from the FDA in a few days, by September 29. This article presents a good summary of the outstanding issues. 
 
and this 2nd article discusses the new approval context for ALS drugs.
FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases
 
 
FDA's CNS division director pledged to withdrawal AMX0035 if the ongoing Phase 3 trial fails. Amylyx's co-CEOs also took the pledge.


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Replies
Msg # Subject Author Recs Date Posted
4205 Re: Food for Thought: The AMX0035 (Albrioza) Situation bubbarayjr 0 9/21/2022 11:31:03 AM
4206 Re: Food for Thought: The AMX0035 (Albrioza) Situation bubbarayjr 2 9/21/2022 12:17:45 PM




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