Dealing with Rejection, the Regulatory Kind

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.

These percentages come from our BIO/BioMedTracker analysis of FDA reviews from 2005-2010 (n=748). The exact percentages for cumulative approval rates are shown in the chart above.

As it relates to content within the CRL, here is an interesting point: When we analyzed 83 NDA/BLA filings that never made it to approval (i.e. were finally suspended by the sponsor), only one was attributed to a manufacturing issue.

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