Pussim, The FDA seemed to be open to trials tha
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Posted On: 06/24/2019 2:39:30 PM
Pussim,
The FDA seemed to be open to trials that evolve, at least they were under Scott Gottlieb, I would hope that a Phase 2 where the results could be reviewed could evolve into a Phase 3 where the patients added could be in a blind test, but they'd be added to the Phase 2 patients who's outcome up to the start of the Phase 3 portion is known. Such an evolving trial reduces cost and time, and in reality you get the advantage of tracking the Phase 2 patients longer, which should add survival data that otherwise isn't available in making the approval decision.
I suspect the key to the initiation of this trial may be financial, any thoughts about that. Also, do you believe they'll do the Phase 2 multi-nationally, if not, where do you believe they'll conduct the trial.
Gary
The FDA seemed to be open to trials that evolve, at least they were under Scott Gottlieb, I would hope that a Phase 2 where the results could be reviewed could evolve into a Phase 3 where the patients added could be in a blind test, but they'd be added to the Phase 2 patients who's outcome up to the start of the Phase 3 portion is known. Such an evolving trial reduces cost and time, and in reality you get the advantage of tracking the Phase 2 patients longer, which should add survival data that otherwise isn't available in making the approval decision.
I suspect the key to the initiation of this trial may be financial, any thoughts about that. Also, do you believe they'll do the Phase 2 multi-nationally, if not, where do you believe they'll conduct the trial.
Gary
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