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DewDiligence

10/31/22 12:01 PM

#244366 RE: DewDiligence #244348

YMAB -52% on Friday's negative ODAC vote.
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DewDiligence

12/01/22 6:04 PM

#244643 RE: DewDiligence #244348

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).