PAR paradigm biopharmaceuticals limited..

FDA delay for ph 3 trial approval, page-7

  1. 723 Posts.
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    Maybe the FDA are just struggling to find something to object to.
    Maybe the FDA's normal business model isn't equipped to handle a gamechanger/blockbuster drug efficiently.
    Maybe PAR have done such a great job with the stack of clinical data that it is taking the FDA a painfully long time to get through it.

    They wouldn't take this long to find a fatal flaw in the data, although they could have spent an inordinate amount of time looking for one.
    I hate waking up every morning to no news, but every day of no news means they still haven't found a reason to say no.
 
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