KZA 0.00% 8.0¢ kazia therapeutics limited

DIPG Panel Discussion, page-9

  1. 1,162 Posts.
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    Yes agreed onesurfed, Sabine Mueller confirmed the withdrawal of panobinostat from the trial without explanation in the recent PNOC discussion.
    Just trying to join the dots.
    FDA accelerated approval of FARYDAK (panobinostat) Capsules, 10 mg, 15 mg, and 20 mg, for multiple myeloma included a required postmarketing trial intended to verify the clinical benefit of FARYDAK.
    Secura Bio, Inc. has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
    Approval is withdrawn as of March 24, 2022.

    The Kazia webinar next week could mention when an application can be submitted to the FDA for an accelerated approval for the combination of paxalisib and ONC-201 and radiation therapy for standard of care DIPG treatment.

    Regards.


 
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