“Treatment of qualified patients will continue until the trial’s data is unblinded”
Is NOT the same statement as:
“Treatment of qualified patients will be discontinued immediately upon unblinding of the trial’s data.”
Think this through. Why would a singular moment-in-time event, which by itself has no meaning (positive or negative) trigger the end of the OLE? What if the drug was found to be supremely effective upon analysis of the data that was unblinded at the moment-in-time event? Why would the FDA want to have stopped administration of an effective drug just because some arbitrary event that tells nothing about the effectiveness of the drug occurred? Especially when that drug was issued OLE based on nothing more than the data that had been available up to that point?
What the statement in the original PR is imprecisely saying is that once the data is unblinded, it can be analyzed. And that analysis will tell the FDA whether the OLE is no longer necessary because a) The drug is safe and effective enough for formal approval, or b) The drug is unsafe (we already know that’s not the case), or c) The drug is ineffective and therefore there is no longer any need for the OLE.
In scenario A, do you think it would make any sense to discontinue OLE administration of the drug between unblinding and EUA, just because the random event of “unblinding” has occurred?
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