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Why TherapeuticsMD Inc Is Getting Clobbered


After providing investors with a regulatory update, shares of TherapeuticsMD (NYSEMKT: TXMD) swooned 10% as of 11:22 a.m. EDT on Monday.

Management at the women's health company told investors that it has received the minutes from its recent meeting with the FDA where it formally discussed the resubmission process for TX-004HR, the company's hopeful treatment for dyspareunia. During its meeting, the company shared additional information with the FDA that they hoped would alleviate the agency's concerns raised in their rejection letter. As a result, many investors were hoping that the company would be able to provide a formal timeline for next steps in this update.

Unfortunately, investors learned today that the FDA is still not willing to provide the company with a formal timeline for the drug's resubmission. However, management did share that it "expects to have additional clarity on the pathway forward for the NDA for TX-004HR in the coming weeks."

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Source: Fool.com

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