RE: Update From Company18 Dec 2025 09:35
OSD - It would depend on the complexity of the data submitted, If complex, which it did not sound like, the FDA can reset the 90 day clock, but if not, it is hard to put an exact timeline. Normally when additional info requested the timeclock is paused and then restarted upon receiving the data. Nothing in the RNS suggests that additional info falls in to the criteria to restart 90 day review period. I think this is just dependent on workload of FDA and news could fall anytime. IMHO.