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DewDiligence

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DewDiligence

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Re: None

Friday, 05/26/2023 2:42:11 PM

Friday, May 26, 2023 2:42:11 PM

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BMY/JNJ—Milvexian—>FDA Fast Track designation for_all_phase-3_indications:

https://finance.yahoo.com/news/milvexian-granted-u-fda-fast-105900364.html

The three Milvexian indications BMY/JNJ are pursuing in phase-3 are: secondary stroke prevention; ACS; and primary stroke prevention in patients with AF—see #msg-171338375.

FDA Fast Track status doesn’t mean much, but it makes a Priority Review of the NDAs somewhat more likely (if one or more of these phase-3 trials pan out).

Please see #msg-169818942 for additional background info.

p.s. This PR was issued yesterday.

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

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