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Posted On: 04/28/2020 12:53:23 PM
Post# of 36519
But the FDA is definitely accelerating cancer drugs, especially for unmet needs. GNBT could possibly qualify for accelerated approval based on the study just published, and then get confirmatory approval later. The odds of this happening are in our favor since we already have the Keytruda/AE37 trial underway.
Also going in GNBT's favor is the fact that we have 10 year data. There is less risk in granting accelerated approval with that data. If, down the line, further studies do not show efficacy, then approval can be withdrawn. But I doubt that would happen.
Also going in GNBT's favor is the fact that we have 10 year data. There is less risk in granting accelerated approval with that data. If, down the line, further studies do not show efficacy, then approval can be withdrawn. But I doubt that would happen.
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