1. In Vivo

Would Pulling A "Breakthrough" Break The Program?

FDA retains the right to pull a breakthrough designation if subsequent data do not back up the promise seen in early clinical results, but a few failures are not expected to unduly hurt the expedited regulatory program.

Biopharma sponsors should know that “breakthrough therapy” designation is no guarantee of success in bringing a new product or indication to market, but whether FDA will ever be willing to rescind a designation and the ramifications of such an action on the growing regulatory program are lingering questions.

A few failures of designated products to fulfill their initial promise of substantial improvements over available therapy likely will not...

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