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Re: DewDiligence post# 244348

Thursday, 12/01/2022 6:04:10 PM

Thursday, December 01, 2022 6:04:10 PM

Post# of 257472
YMAB receives CRL (as expected given the negative panel vote):

https://www.globenewswire.com/news-release/2022/12/01/2566388/0/en/Y-mAbs-Announces-Complete-Response-Letter-for-Omburtamab-Biologics-License-Application.html

The CRL includes a recommendation for meeting with the agency to discuss adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.

This was an expected result given the (unanimously) negative vote from the advisory panel (#msg-170316756).

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the foremost piece of B.S. ever promulgated
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