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Re: beartrap12 post# 66019

Tuesday, 07/05/2016 3:54:03 PM

Tuesday, July 05, 2016 3:54:03 PM

Post# of 701238
It's a theory, and yet validation would have to be met. Nothing untoward, good news, part of the protocol. For all practical purposes, once the pipeline + enrollment are near the estimated trial size, the phase III batches are theoretically complete, and if transition to commercial production has not reached validation, the trial might be placed on a temporary partial hold until such time that validation is met in order that the commercial manufacturing process meets the necessary validation in order to be made available to the public. In the meantime the surrogate/primary endpoint continues to mature, as do the secondary and tertiary endpoints. All blinded. It's a theory. I wonder if they could use hospital exemption production to aid translation from clinical to commercial?

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