Oh OK. I understand.If I was confused by your argument it is because I can see it is still a false argument.You are arguing that the FDA has gone against their SOPs in accepting the BLA by using an example post BLA acceptance CRL.
Your point is stupider than I thought it was. I'm not going to bother looking up whether the evaluation process was "alinear" because it seems to be irrelevant to the argument that the FDA wouldn't have accepted the BLA if they felt the CRL wasn't actually addressed.
Oh OK. I understand.If I was confused by your argument it is...
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