RE: Oh dear further NICE delays22 Nov 2023 09:27
Prion, with the exception of Budd and Matthew Fowler, all of these people resigned 5 yrs or longer ago so I don't think there's a mass walk out or anything.
Just looking back over RNSs to see if I can work out what ever happened to the FDA application. There was an RNS in Oct 2022 saying GDR were in discussions with FDA to ascertain which route they could engage with, 510k or De Novo. Just one month later this one liner was put in the Final Audited results RNS.
'We have commenced the process for FDA approval, as we see huge potential for AIHL which is additionally supported by the litigious nature of the US market.'
So that's Nov 2022 the process was actually started and since then nothing from the company on FDA. I will ask at the results presentation what the current status is of this process. It could be that it's gone cold or been rejected and the BOD in their wisdom decided not to inform the market, or it could still be active. Either way it would be good to have this confirmed from the CEO.
I will also ask how the BODs feel they're doing with regard to being 'committed to improving engagement with share holders' . Should be an interesting meeting but I am fairly sure they will pre select questions already submitted and avoid having to answer any awkward questions.