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Posted On: 05/18/2021 10:34:04 PM
Post# of 148899
Re: Bored Lawyer #90803
I agree that the BLA question was not answered
The cmc (manufacturing) section was already submitted once so resubmitting that means very little
Why not say when the clinical section will be submitted as that was the major issue before.
We are more than a year late and still don’t have a timeline.
That is frustrating to me.
IMO
The cmc (manufacturing) section was already submitted once so resubmitting that means very little
Why not say when the clinical section will be submitted as that was the major issue before.
We are more than a year late and still don’t have a timeline.
That is frustrating to me.
IMO
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