PAR 2.13% 24.0¢ paradigm biopharmaceuticals limited..

Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-168

  1. 1,567 Posts.
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    Agree that deal time is during P3 (and we do have MPS as well which is more advanced and still a sizable prize - the theory about BioMarin being interested seems pretty strong).

    I think its the whole point about 008 - early data on the structural biomarker endpoints, which indicates DMOAD, which makes the asset more attractive, which increases deal value, facilitates negotiations during P3, etc.. Its the main reason we are doing 008 early (and outside the P3), to get this data in house to leverage discussions during the P3

    Sorry to harp on about DMOAD, but its pretty mind blowing. Since that link I posted earlier was pretty dodgy I'll try again........ FDA STRUCTURAL ENDPOINTS FOR OA

    Further to this paper by FDA in 2018, the OARSI wrote this piece which really spells it out the route to DMOAD completely, and seems to mesh with our trial structure including a biomarker as a surrogate endpoint,.....RESPONSE TO FDA ON STRUCTURAL ENDPOINTS

    Something for @Mozzarc to get his teeth stuck into.


 
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