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Post# of 708881
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MI Dendream

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MI Dendream

Re: vator post# 439341

Friday, 01/28/2022 8:24:17 AM

Friday, January 28, 2022 8:24:17 AM

Post# of 708881
Addressed in my reply already.

FDA does not swing from the hip. Add patients to your study or change primary endpoint or both.

Decide an ECA is an acceptable, approvable design when a validated database does not exist…implausible.

Change your only pivotal trial design voluntarily for your lead asset with no existing product portfolio, please explain how this is not material? How about after data lock?

Sorry, bonkers
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