Aquestive Therapeutics Inc.: dibutepinephrine

We note the HF study used a placebo with a different formulation compared to dibutepinephrine sublingual film that limits interpretation of these results.

The comments included in this communication reflect the deficiencies that CDER has determined preclude approval of the NDA in its current form, and do not represent a final decision by the Agency on approval of the NDA or the issues raised in the pending citizen petition.