Amid the FDA chaos there is a new program that cut
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Amid the FDA chaos there is a new program that cuts review times from 10-12 months to one to two months some companies focused on addressing unmet public health needs, boosting domestic production, or delivering innovative cures. That sounds like us.
Reviewing thousands of pages of a BLA in one to two months with a severely reduced staff? Expect many cases like aduhelm or even worse to slip through.

