Hi all,
"The FDA does appear to have significant reservations about Amylyx’s drug, though. In briefing documents released ahead of this week’s advisory meeting, agency scientists argued that the main evidence Amylyx gathered "was not exceptionally persuasive." The staff also said it was "challenging to interpret" how the drug performed in a key clinical study, as, among other issues, Amylyx made "potentially incorrect assumptions" when assessing the data.Shares in Amylyx, which had accumulated a market value greater than $1 billion, fell by more than 50% on news of the FDA's views".
Agree Densey !
Ref : Biopharma dive 28/03/2022
Ann: First Patient Dosed in MND Phase 1/2 Trial, page-158
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