PAR paradigm biopharmaceuticals limited..

We just submitted an IND - So now what?, page-6

  1. 4,895 Posts.
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    Torpy, super work, nice to compare...

    Interesting that 006 doesn't specifically mention biomarkers but clearly Donna (CMO) did mention it in the recent R&D day.
    Its a bit fluid (pardon the expression) but I think it will depend on what FDA deem to be enough data as to whether we could include DMOAD data to broaden label just based on 006 (I doubt 008 would be enough, 30 patients , 60 in total is too small) or whether a separate trial again would in fact be required to give power to the results/stats...and lead to a broadening of the label at a future point in time.


 
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