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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