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Fly News Breaks for August 18, 2017
TXMD
Aug 18, 2017 | 06:53 EDT
Jefferies analyst Matthew Andrews says data from the Women's Health Initiative observational study of vaginal estrogen use in postmenopausal women suggest that vaginal estrogen doesn't increase the risk for key safety issues while providing a coronary heart disease, fracture, and mortality benefit. The sample size and seven year follow-up appear to be robust and adequate to satisfy FDA scrutiny, Andrews tells investors in a research note titled, "WHI-OS Safety Data Look Solid...Another Step Towards '004 Approval." These data, coupled with two supportive Finnish studies, and FDA acknowledgement of no TX-004HR, or E safety signal, continue to suggest that '004 remains approvable, the analyst argues. He keeps a Buy rating on TherapeuticsMD with a $15 price target.
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