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biosectinvestor

12/31/21 7:19 PM

#431089 RE: HappyLibrarian #431083

It’s reform required by law. The Act of Congress is a few years old now. It is the law and very shortly will be clarified by the FDA as to implementation.

Happy New Year HL!
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biosectinvestor

12/31/21 7:21 PM

#431091 RE: HappyLibrarian #431083

Right to try was never what people said and I never talked about it because the law got messed up. This is actually different. The laws are clear, the policies are already drafted, they just have to be finalized. On the positive side, the only thing left is for the agency to incorporate more industry friendly changes to already announced initiatives based on comments, which they can do or not, it’s not a requirement to get to where NWBO needs to get.