Again, like every other company they've got a coup
Post# of 145808
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Again, they take their time/work to make everything in the BLA exactly like FDA liked in order to avoid a CRL/decline of application.
Since leronlimab is safe and highly effacious, only manufacturing could be an issue, but AGC is a decent company and they took their time.
So, once BLA is submitted, 5% chance it gets rejected IMO.
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