I don't really feel they have to NR any more than they have by saying they would apply within the next 90 - 120 days. What I might caution is that my memory tells me that they stated that they would apply within 90 - 120 days, not that they would have an answer by then. Below is what was in the Nov. 18 presentation slides.

"Breakthrough Therapy status filings, both FDA and EMA, over the next 90-120 days"

It says filings over the next 90 - 120 days. If you add the 60 days for approval to the 120 days, it could be up to 6 months or mid-May. Nothing wrong with an NR when they file or did file but I doubt it is mandatory.