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FeMike

05/02/23 11:55 PM

#590355 RE: Jarheef #590341

Not gone for approval years ago. But should have been more prepared years ago. I absolutely think applications should have been submitted in 2022.

Manufacturing was set up with CRL and the BLA could have rolled had LP maintained that relationship correctly.

Now the focus is on an MAA in the UK and both price and capacity are issues.

It’s just been so poorly managed the past 5 years that everything is fuzzy now. Just really, really bad management team with no vision.