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Re: mjbaker84 post# 135895

Thursday, 12/24/2020 9:06:33 PM

Thursday, December 24, 2020 9:06:33 PM

Post# of 232567
FDA allowing patients that met original CD12 inclusion criteria to be administered the active drug.

It’s a massive tell by the FDA. They wouldn’t allow the open label extension without confidence in the 1. Safety and 2. Outcome measures of CD12 study. It’s a massively important decision prior to unblinding and granting EUA prior to formal FDA approval

I suspect they feel a sense of pressure knowing other countries are going to grant approval. Inventory will be scarce..
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