A boring sunday evening so its interesting looking at the FDA...

A boring sunday evening so its interesting looking at the FDA website on breakthrough designation and trying to apply it to the current NEU situation. I've highlighted the bit I found particularly interesting. Correct me if I'm wrong but I understood it was the FDA that requested more "information" on the phase 2 results...

......"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).To determine whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.......
..........If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if:
(1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and
(2) the remaining drug development program can benefit from the designation
Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.