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Jesspro

01/15/21 2:08 PM

#11712 RE: biotech_researcher #11710

BR, show me one drug, just one drug, for an unmet medical need that passed P3 trial with flying colors that was disapproved by the FDA. And BTW, it’s AMRN not ANRN.

northern vortex

01/17/21 9:24 AM

#11723 RE: biotech_researcher #11710

If the FDA turns down approval for VOC, they better be ready to deal with the Lupus community. But maybe that is why they granted approval for Benlystra. lol.

Did you know that BENLYSTA was studied in the largest and longest lupus nephritis clinical trial ever conducted - i.e. 2 years. LOL.

To read about dosing and administration, etc see: https://www.benlysta.com/about-benlysta-for-lupus/lupus-nephritis/

Thinking more logically about AUPH, I suggest that when the FDA did not require an AdCom meeting and granted priority review for VOC; it sort of tipped their hand regarding approval. The only item still in doubt is the label. ……. Meanwhile, I have been buying on weakness. ……. Good luck to all.

P.S. - I wonder when Benlysta's patent(s) run out???