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Notable Calls reports that, according to Goldman Sachs, 70 members of Congress (mostly female) have sent a letter to the FDA emphasizing their support for increasing patient access to TherapeuticsMD's (TXMD -2.2%) Yuvvexy (estradiol softgel capsule) for the potential treatment of women with moderate-to-severe dyspareunia (vaginal pain during intercourse).
- According to sell-side shop Jefferies, more patients will have access to the product, once approved, if the Black Box warning is removed from the label, a realistic objective considering the low-dose non-systemic estradiol formulation in the product. Jefferies believes this would expand the available market to 32M from 8M.
- The company's marketing application is currently under FDA review with an action date (PDUFA) of May 7, 2017.
- Previously: TherapeuticsMD's TX-004 HR successful in late-stage trial in dyspareunia (Dec. 7, 2015)