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Re: jmkobers post# 3817

Friday, 06/09/2023 4:11:59 PM

Friday, June 09, 2023 4:11:59 PM

Post# of 9090
I think your 60/40 probability of approval for CD is too pessimistic. There is not likely any facility inspection required as the bulk process issues were resolved with the Daxxi approval and they just had a prior approval supplement for the Ajinomoto fill/finish facility granted. I would expect the review of the CD indication to be based almost exclusively on the clinical trial data.
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