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Fly News Breaks for August 30, 2017
TXMD
Aug 30, 2017 | 07:29 EDT
Oppenheimer analyst Jay Olson says his ongoing assessment of the next steps for TX-004HR lead him to believe the setup is favorable for TherapeuticsMD based on what he sees as continuing collaboration with the FDA. His view is shaped by the FDA's willingness to review the WHI observational study of 93K women as it considers what additional information is required for re-submission of the TX-004HR NDA for which the company received a CRL, citing a lack of long-term endometrial safety data as the only approvability issue. The analyst reiterates an Outperform rating and $10 price target on the shares.
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