Cottenmouth, 

 See the 'Breakthrough Therapy Question' thread from Jan 5th for the full conversation but here are a couple excerpts. 

 I asked IR for clarification on the timeline with the below email: 

"I'm looking for a bit of clarification regarding the timeline for breakthrough status filing with the FDA that Don mentioned in the December 6th conference call. 

When he stated "As we’ve mentioned before, we’re applying for breakthrough therapy status with both the FDA and the EMA. The process will take 90 to 120 days", did the 90 to 120 days include the expected response time from the FDA, or is the FDA's expected response in addition to those 90 - 120 days?"

They responded with the below answer: 

"Our expectation is that the process will include a response by regulators. We stress that this is our expectation and that the regulators are not bound by any time estimates given to the company.

Regards,"

And in regards to the FDA, they respond to BT applications within 60 days, according to their website: 

What are the timelines for FDA to respond to a breakthrough therapy designation request? 

FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request. 

https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies