Wednesday, October 27, 2021 12:56:03 PM
NP's knowledge of the status of the BLA was based on the information coming from Kush Dody of Amarex. Upon reading the emails carefully, it appears NP thought only the CMC data was still necessary to finalize the BLA and get it off by the deadline - which Dody said would take a week.
That was in April of 2020
NP wanted the BLA received by the "deadline" and apparently thought it was, based on the assurances of Dody, (other than completing the CMC info) about ready to go. He, based on the communications, appears unaware of the incomplete mess the BLA turns out to be.
It further appears NP is under the illusion that the BLA is completed and if there's any "minor stuff" that needs fixing, they can attend to it "after-the-fact."
So, in my estimation, NP's actions are a direct result of the information coming from Amarex/Dody - the company contracted to complete the BLA. Only later does he find out that the BLA is a disaster.
That had to hurt!
IMO
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