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Post# of 14871
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Just the facts maam

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Just the facts maam

Re: Just the facts maam post# 13873

Wednesday, 06/15/2022 4:44:14 AM

Wednesday, June 15, 2022 4:44:14 AM

Post# of 14871
Correction: The time between AbbVie submitting a Certification request for the "Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain" to announcing the PDUFA target date was 10 months and 8 days not 9 months and 8 days. AbbVie did announce that they submitted an NDA to the FDA 3 months and 4 days after Trial Certification submission and announced receiving a priority review 1 month and 21 days later.

Hopefully Libi keeps similar timelines. If so, it pushes approval towards mid January. Expected launch date for Amgen's Humira biosimilar, Amjevita, is Jan. 31, 2023
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