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Msg  47280 of 47592  at  8/5/2022 10:58:15 PM  by

ashtonb22

The following message was updated on 8/5/2022 11:04:02 PM.

Delay on other fda pdufa bc inspection

Endpoints News: FDA delays PDUFA date for Libtayo lung cancer combo; Swedish biotech hit flunks PhIII for chemo-enhancing drug.

We recently were informed that an FDA travel complication relating to scheduling a routine clinical trial site inspection in Eastern Europe will likely delay their decision until after our September 19 PDUFA date, Regeneron president and CEO Len Schleifer said during the call.

He added that a new inspection date has already been scheduled, so the delay shouldnt be too lengthy and that Regeneron doesnt expect it to meaningfully impact our launch plans assuming FDA approval.

https://endpts.com/fda-delays-pdufa-date-for-libtayo-lung-cancer-combo-swedish-biotech-hit-flunks-phiii-for-chemo-enhancing-drug/

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Msg # Subject Author Recs Date Posted
47282 Re: Delay on other fda pdufa bc inspection tm3912 7 8/6/2022 7:40:26 AM




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