Yes, that’s true but it doesn’t take into consideration the new eStar submission platform. So, I did some investigating of eStar and my impression is that eStar is a comprehensive submission platform that doesn’t allow the submitting company to be less than complete with everything that is needed in order to fulfill the requirements for approval.
After going through a dozen presentations of eStar, I feel that the submission will get a quick turnaround on the necessary info needed to green light the full review. My expectation of approval, if it’s coming …and, I personally think so, is mid to late May …or sooner. I really don’t think the decision from the FDA will go beyond 3 months from 3/21. That’s my educated guess.GLTA!