RE:RE:Is FDA submission material enough for an NR? plantrader wrote: It would also be nice to hear about this schedule (CSS) disclaimer being resolved for a little more certainty on submission timeline. To me it reads that the 450 assessments in 4Q 2022 & then at that point the the company will begin work on compiling a clinical data report. To me, this opens the door for the clinical data report not being ready/submitted until sometime in Q1 2023 at the soonest. Not too long to wait, just trying to get a feel for the schedule expectations.
"Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments and biostatistical review and analysis"
Not much happens with the bureaucrats in D.C. between mid-December and mid-January with holiday revelry and vacations and all. Have to leave the headline stuff for the politicians returning and seating the new congress. Meanwhile, Biden gave forewarning of another round of infections (RSV, flu, Covid) coming to infect 100 million Americans. Slap on a daily nicotine patch (14 mg) and take a daily dose of 1000mg EDTA to ward off those shed spike proteins from others.