For 3rd time, the FDA and its new commissioner dropped safety issues and trial demands, clearing the path for snubbed therapy
TherapeuticsMD $TXMD was slammed on May 8 when the FDA formally rejected its application for a vaginal pain medicine dubbed TX-004HR. Regulators wanted more safety data, which would have required a new study and years more work.
Then, one day later, Scott Gottlieb won confirmation as the new commissioner of the FDA, and that may have made a huge difference in the biotech’s fortunes.
This morning TherapeuticsMD, which had said it would appeal the decision, says the FDA has relinquished its demands and will allow them to resubmit their application in a matter of weeks. Instead of a pre-approval study, regulators say they will now be satisfied with a post-approval trial.
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