RE: I suspect it won't be long before the MT-RNR1 FDA application,6 Jul 2025 13:20
Trying to stay away but EmC's posts force me to step in.....
Please watch this link EC. 20mins in there is a slide which clearly states FDA submission end of 2026. James Cheek, former CEO, also stated in a previous investor presentation that likely FDA approval for MT-RNR1 would be early 2027 so that's consistent with this most recent presentation given by the new CEO Gino Miele. On the right of the slide it doesn't even give an estimate for FDA submission or approval for CYP2C19 so it's a long way off.
https://www.youtube.com/watch?v=MrfHKoBtmPM
Whatever your thoughts on FDA, I think the supposedly imminent news on the publication of the implementation guide is going to be the deciding factor in whether or not GDR survives an early lowball takeover offer. If it comes in the next two weeks and is clearly positive and affirms a national rollout then there will be many happy and hugely relieved share holders here. That would put some wind in the sails of the share price and lead to Gino being able to ask share holders to vote in favour of a solution to the ongoing financial struggles.
For me the game changer in that recent presentation was the huge increase in potential revenue here in the UK. Really try not to post but had to clarify this FDA nonsense from EC.