Ther­a­peu­tic­sMD flags “de­fi­cien­cies” in NDA; CRUK, NCI col­lab­o­rate on RAS in­hibitor re­search

→ Bo­ca Ra­ton, FL-based Ther­a­peu­tic­sMD $TXMD is flag­ging some se­ri­ous prob­lems for their new drug ap­pli­ca­tion at the FDA. In a state­ment to­day the com­pa­ny said reg­u­la­tors had iden­ti­fied “de­fi­cien­cies” in their ap­pli­ca­tion, though it’s not ex­act­ly sure what those de­fi­cien­cies are. They’re seek­ing a mar­ket­ing ap­proval for TX-004HR, “an in­ves­ti­ga­tion­al bio-iden­ti­cal 17β-estra­di­ol vagi­nal soft­gel cap­sule for the treat­ment of mod­er­ate-to-se­vere vagi­nal pain dur­ing sex­u­al in­ter­course (dys­pare­u­nia), a symp­tom of vul­var vagi­nal at­ro­phy (VVA) in post­menopausal women.” The biotech says it plans to find out what the de­fi­cien­cies are and re­solve them AS­AP.

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