How can Teva submit an ANDA for Korlym without bioequivalence data gathered by Teva? There doesn’t seem to be any indication they did so?
On Feb 5th $CORT tanked over 20% after Teva announced they were submitting an ANDA for CORT’s drug, Korlym (mifepristone).
I can’t find absolutely anything on a Teva trial to show bioequivalence to Korlym. I can’t even find any single webpage that ties Teva to Korlym outside of the websites that announced the Feb 5th news. I’ve searched through their website, googled tons of a combinations of the words “Teva” “Korlym” “mifepristone” “bioequivalence” etc., and looked through Tevas SEC filings.
Does anyone have knowledge or thoughts on this? Can Teva somehow submit an ANDA to the FDA without a trial to show bioequivalence? Or did they complete a bioequivalence trial without affording investors an indication that they’re doing so beforehand? To my knowledge, they need to show that their formulation is bioequivalent before submitting an ANDA.
ANY help or thoughts are much appreciated!
submitted by /u/Semi-ColonNightmare
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