If drug is granted AA, the company is still required to conduct a confirmatory trial to evaluate a clinical endpoint that directly measures the clinical benefit.
However, such a confirmatory trial should already be underway at the time the marketing application is submitted.
Usually, the trial population would be the same as the one used for Accelerated Approval. However AA would make the drug commercial availability and may make such a trial difficult to enroll.
In such a case, a confirmatory might be conducted on a different, but related population that is capable of verifying the predicted clinical benefit for which the AA was granted in the first place.
And whata-ya-know, we've already got one such trial underway. Think "expanded access".
Does NWBO management think of everything or what? :)
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