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Post# of 828681
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brazen22

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brazen22

Re: GoodGuyBill post# 827953

Thursday, 05/28/2026 11:56:16 AM

Thursday, May 28, 2026 11:56:16 AM

Post# of 828681
The problem is that there are several other explanations that fit the same facts.

A company seeking approval has to act like approval is possible. It has to prepare. It has to show manufacturing readiness. It has to have leukapheresis, staffing, facilities, QA systems, tech transfer, and capacity planning in place or in progress. That does not mean approval is forthcoming . It may mean they are trying to satisfy prerequisites before approval can happen.
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