Replies to post #3770 on PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

PLX

In the U.S.A. Chiesi resubmitted the BLA to the FDA on November 9, 2022. This included data for dosing every four weeks. On December 5, 2022 the FDA accepted the pegunigalsidase alfa BLA, with a PDUFA (action) date set to May 9, 2023. There has been no announcement as to whether the FDA will call for an Advisory Committee hearing.

GMDA

As part of its ongoing BLA review, FDA issued an information request and viewed the data in the response as a major amendment, resulting in an extension of the omidubicel Prescription Drug User Fee Act (PDUFA) date from January 30, 2023 to May 1, 2023. The agency also rescheduled Gamida Cell’s late-cycle meeting to the first quarter of 2023.

May 2023, a make or break for me!