FDA Prediction, page-43

CUV was not a de novo class, their case first submitted June 18 and docs were required 3 months later. Update Ann Jan 19 says approval by July 19 but was delayed. If it was a backlog caused from Trumpman administration bug at least we know FDA start to speed up things now.

Back to RAP ETA estimate slight adjustment is needed here. REDBAR informed the questions FDA raised were answered back in July, If we were held back for the same reason the process would have resumed.

Taking estimated process time for de novo approval within 3-6 months from the answer (total 6-9 month without a delay), here we just had the new policy signed last week let’s assume that baby can kill half of the time which is 1.5-3 months time from questions answered if not more. Our ETA is between mid Nov and late Dec.

Also worth to say RAP team is a good student in the class to impress the teacher if there’s time bonus we deserve it: the homework sheet includes 2 years on the US trials and consultations, experienced board advisors and experien group on board with us, great trial data above threshold, maybe add CE and TGA clearance surely that won’t hurt.

on the silver side they may have a limit of monthly grant and some hard nuts in front of RAP could take extra time or things may slow down prior to Xmas, god bless our management if they did everything they can the wish them good luck

GLTA FDA is another 60% jump day as CUV did today