Analysts see the shortened timeline and absence of an adviso...
Analysts see the shortened timeline and absence of an advisory committee meeting as positive signs for unrestricted approval. The FDA's eagerness to expand the label and transition from accelerated to traditional approval is evident in the expedited review timeline. This could set a precedent for other gene therapies seeking FDA approval, despite Elevidys not meeting its primary endpoint.
Prospects Look Better for Sarepta Gene Therapy, Sending the Stock Up Again -- Barrons.com
Disclaimer: The above information does not represent the views of Moomoo Technologies Inc. (MTI) or constitute investment advice related to MTI and its affiliates.
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