JT, at H.C. Wainwright’s CC next Tuesday, the take home I want to come away with is if there is any further communication w the FDA of using existing pozi data from the Z20 (or MDACC) trial to seek BTD or Fast Track. You don’t even have to give a concrete answer since that might jeopardize ongoing communications. A “no, we are waiting for the 1st cohort to mature” or “we’ll always look for an opportunity to move pozi development forward faster but at the very least, we’ll have topline and further communication in the 4th Q". Although, we still want to know the status of Rolontis, that’s secondary in my book.
JT, the reason I ask about pozi is that you have roughly half the 1st cohort patients in the trial recruited by June 2018. Here’s how I came up w that. If it took 14.5m to enroll 87 pts cohort 1 patients in the Z20 trial, and say due to the ramp up of trial sites it took two-thirds of 14.5m to enroll half the patients (i.e. ~44 patients). Two-thirds of the time from Sept 13, 2017 (start of trial) to Dec 31, 2018 (full enrollment) is roughly 9.5 months or end of June 2018. So you have more than 9 months data for the first 44 patients of the 1st cohort which is considerably more than the 30 patients that you needed to submit from the MDACC trial. So please alleviate some concerns on why wouldn’t BTD or other accelerated approval programs (other than Accelerated Approval prior to Full Approval) be considered. And I'm sure, previously treated patients who have the EGFRex20in mutation would love to have that option.
