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DewDiligence

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Re: bladerunner1717 post# 241354

Thursday, 06/30/2022 5:42:03 PM

Thursday, June 30, 2022 5:42:03 PM

Post# of 257470
PRVB—Teplizumab PDUFA date extended 3mo to 11/17/22:

https://www.prnewswire.com/news-releases/provention-bio-announces-extension-of-fda-user-fee-goal-date-for-teplizumab-to-november-17-2022-301579153.html

As part of its ongoing review and communications, the FDA informed the Company yesterday that it considers a timely response to an information request made earlier this month to be a Major Amendment to the BLA resubmission, requiring additional time for the Agency's review.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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