RE: Day 9010 Feb 2026 09:37
Hi OSD, for me, like everyone else, its a guessing game.
As we know there was the RNS on the 12 Nov telling us about the request for additional info / clarification. At that date the company said they would respond to the FDA 'as soon as possible'.
Around the 18th December, both yourself and another posted feedback from Tim at IR saying the response had been submitted. So we know they submitted at some point in that month inbetween the RNS and the investor relations email.
It could have been a few days after the RNS or it could have been early to mid-December, we don't know.
With the 90 days chat, my understanding is that this relates only to the initial submission. The FDA gave their response after 90 days, which was a request for info.
As far as I'm aware, there is no timeline for the FDA to deal with responses to clarification requests. Whereas if the request was made within the initial 90 day period then the clock would stop and restart after receipt of response.
As the last RNS for annual results states, the company has had no feedback on timelines from the FDA. So it could land anytime now, or take a few months more. We simply do not know.