No news on that front.

From what I understand, Breakthrough therapy designation gives you fast track and help from FDA. Doesn't mean we're going forward with our data. Are we waiting on something?

A drug that receives Breakthrough Therapy designation is eligible for the following:

• All Fast Track designation features
• Intensive guidance on an efficient drug development program, beginning as early as Phase 1
• Organizational commitment involving senior managers

Breakthrough Therapy designation is requested by the drug company. 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.