PAR 2.04% 25.0¢ paradigm biopharmaceuticals limited..

After conversations with Simon White we got this:"Upcoming news...

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    After conversations with Simon White we got this:
    "
    Upcoming news flow:• The 12-month clinical outcome data from the PARA_OA_008 phase 2 clinicalstudy is expected to be reported in September 2023. Data presented will includechange from baseline in WOMAC pain and function data along with patient globalimpression of change (PGIC) and rescue medication measurements followingiPPS treatment compared to placebo at the Day 365 time point.

    • The quantitative analysis of MRI results from the day 168 timepoint ofPARA_OA_008 is also expected to be reported in September 2023. Previously,Paradigm reported a semi-quantitative analysis of the structural observationsfollowing iPPS compared to placebo on cartilage volume, bone marrow lesionsand marginal osteophytes. The quantitative analysis will provide further detaileddetermination of the structural changes occurring in the joint following iPPScompared to placebo.

    • Top-line data from the phase 2, double-blinded and randomised MPS VI clinicaltrial is expected during Q4 CY2023. Participants in the study are dosed weekly for24 weeks with the primary endpoint being safety, followed by secondary endpointsof improvements in pain and function.

    • The manuscript of PARA_MPS_001 Phase 2 clinical trial data is being completedand will be available following peer review and publication.

    • The PARA_OA_008 manuscript has commenced drafting with sections from theday 365 data to be added once available. The manuscript will then be prepared forpeer review and publication in a scientific journal.

    "
    What was/is most important is that by end September there should be just the time taken for a tick on the dosage level from the independent authority, and the request to FDA to go ahead to get a DMOAD label with confirming trials already discussed.

    The other conversations i had were on the importance of a deal, and clarity over full remaining trials.
    PAR investors need to make sure the Board understands we dont want more than 1 more CR and much prefer a deal on MPS.
    SO call or write to Simon White.
    All IMO. DYOR.
 
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