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Re: exwannabe post# 559660

Sunday, 01/15/2023 12:12:00 PM

Sunday, January 15, 2023 12:12:00 PM

Post# of 823587
No, they did not say it was based on “data” from the trial and I know some want the change in endpoints to effectively not have been approved, but the were and prior to unblinding. Further the SAP was drafted by a completely blind third-party entity, working with expert doctors also not connected to the trial.

They clearly made every effort to ensure that these false arguments cannot be made.

And we have discussed other circumstances even a BP that already had a special protocol assessment (SPA) that ultimately revised their endpoints with the approval of the FDA before unblinding and despite that scrambling the SPA.

Repeating facts that are not necessarily true together with speculation that is false that it wasn’t approved or that it violated core concepts around revising SAP’s doesn’t make those related statements more true the more frequently those false details get repeated.
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