PYC pyc therapeutics limited

FDA pediatric voucher application, page-6

  1. 6,831 Posts.
    lightbulb Created with Sketch. 383
    as you said on the other thread, now it is making some sense...

    "Just something Rohan said at the end of the call that stuck in my mind is as soon as PYC launch the IND enabling studies at the end of the first quarter next year, assuming that they are successful with lead up work, that's their stake in the ground:
    - for the process that everyone else coming after them have to replicate. Others will also have to go into a higher statistically powered clinical evaluation to demonstrate outperformance of PYC's molecule.
    - as well as getting first in class, if PYC happen to be first in class treatment for the treatment they are going after.
    So it's effectively a stake in the ground giving early proof you have some time ahead of the others at the backend, in the revenue generating phase of having a marketed drug (if you get through the clinic).""

    so putting 2 and 2 together, we get the drug
    proved, named
    , and lodged, and ask for this Priority revie from FDA . sounds like a plan with substance!
 
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