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Posted On: 02/14/2020 8:29:24 PM
Post# of 155045
Quote:
They have "96%" (my number) committed to submitting at least one part of the BLA almost every month since September (or earlier). Yet, they haven't submitted either of the remaining two parts. As I said, I don't think it will happen in the next 60 days. Something is holding them back.
(And, no, I do not believe all of the excuses, such as blaming FDA or manufacturer. They have said it will be submitted in 4 days and then missed the deadline. Really strange.)
With the BLA asking for all data for the monotherapy trial they're basically compiling an entirely new BLA for monotherapy.
Who is putting together the clinical and CMC portions of the BLA, Cytodyn or Amarex and AMG? I really can't fault Amarex writing up an entire new BLA is a herculean feat. However AMG is certainly falling down on the job.
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