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Wednesday, November 03, 2021 6:10:04 PM
1) Amarex submitted the BLA - not NP. As the CRO, Amarex is fully responsible for the content of the BLA, not NP. LOL
2) submitting an incomplete BLA is grounds for rejection - it's not a "false statement".
He is cooked. On the BLA Application it clearly states "Warning: A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001"
The only one that's "cooked" is clearly Amarex.
My comments are just my opinions and should NOT be taken as investment advice.
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