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Re: skitahoe post# 645206

Saturday, 11/04/2023 6:28:46 PM

Saturday, November 04, 2023 6:28:46 PM

Post# of 704990
Gary,

I believe you are correct.

The phase 3 trial followed the trial design and the locked data processed according to the SAP.

The submissions must be applied to and approved based on the trial protocol and treatment administration, otherwise you would not have a consistent analysis to base approval on.

Additional trials and data may follow asap, including combination testing and compassionate care results but first approvals must be based on the phase 3 trial.
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