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Dynavax Technologies Corporation Message Board

  • milon5167 milon5167 Mar 16, 2013 6:26 PM Flag

    Dealing with Rejection, the Regulatory Kind

    The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days?

    It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd attempt, the cumulative percentage climbs to 83%. After that there is little data to support that subsequent submissions materially impact the probability of approval.

 
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