MSB 2.89% $1.25 mesoblast limited

Ann: FDA Accepts BLA for RYONCIL and Agrees to Priority Review, page-123

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  1. 1,419 Posts.
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    1. re PDUFA action date of 30 September 2020, positive FDA news for others (here's hoping):

    https://hotcopper.com.au/data/attachments/2112/2112927-ffc34a9b63ae4fc9ea4a0223724ce9ed.jpg

    https://hotcopper.com.au/data/attachments/2112/2112933-40e51321e3ca986f93cc3bb712cc0384.jpg
    https://endpts.com/incyte-nabs-2nd-ever-approval-ahead-of-schedule-as-fda-insists-it-can-still-review-on-time/

    2. re planned Advisory Committee Meeting, looks like a relevant 8 May 2020 meeting but MSB not on the draft agenda, and the draft roster looks a bit lightweight to me (no offense intended):

    https://hotcopper.com.au/data/attachments/2112/2112981-e495ea2e697ee12a5e6d8a15de5ede55.jpg
    https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-may-8-2020-meeting-announcement-05082020

    GLTAH!
 
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