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Tuesday, March 20, 2018 6:01:10 PM
Now... if there was a problem with pseudo-progression that originally appeared as if patients were progressing sooner than they really were... and that a halt may have been the result of that... do you really think the FDA DID NOT peek behind that curtain? Especially considering that the halt was then lifted a full year and a half later?
Because of these stuffy stupid dumb anal-retentive-type FDA rules - they HAVE TO not unblind until there is enough separation to make sure that the FDA does what they are supposed to do in such cases - approve.
In the meantime, the protocol states that the OS arm of the trial is open label. They have every right under the sun to publish that unblinded data. And in doing so, it will hint at what the real numbers are while we wait.
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