havasu: I suspect that the FDA "blinding" protocol
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Posted On: 07/05/2020 3:53:20 PM
havasu: I suspect that the FDA "blinding" protocols do not anticipate a situation where a single laboratory (BP) doing a single lab test (in this case Patterson doing receptor occupancy) is effectively unblinded as to not only which patients receive placebo but also the primary outcome.
IMO even that knowledge does not constitute inside information or a breach of the FDA blinding protocol. BPs knowledge is limited to the MOA theory. BP believes the MOA has predictive power; in these trials or any trial. However, no matter the intensity of that belief the MOA is, as of this date, untested and unconfirmed. Thus assuming the trial validates leronimab efficacy it will at the same time largely confirm BP's theory of of leronlimab's MOA. Would the reverse ever be possible??
IMO even that knowledge does not constitute inside information or a breach of the FDA blinding protocol. BPs knowledge is limited to the MOA theory. BP believes the MOA has predictive power; in these trials or any trial. However, no matter the intensity of that belief the MOA is, as of this date, untested and unconfirmed. Thus assuming the trial validates leronimab efficacy it will at the same time largely confirm BP's theory of of leronlimab's MOA. Would the reverse ever be possible??
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