yes ok, then they do have a right to reject the advice of the committee if they recommend halting due to early efficacy. Given what we've just seen with overturning the ODAC recommendations, if I was Dr Itescu I would be very cautious in halting the trial early. In a normal setting the FDA would accept the trial as a success if the Bayesian analysis showed overwhelming efficacy at an interim readout, but the sponsor is ultimately responsible for the success of the trial, and if they think there's a chance that a trial not run to full course would be rejected for approval by the FDA then they'd be obligated to continue the trial until they were sure the results were good enough to get approval for the treatment.
This long boring pause between the CRL and the next piece of news is going to be so painful. Gotta amuse myself with my other holdings until there is some news. What a wild ride on this share, hey!
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