RE: Predictions on close!?17 Feb 2023 19:44
FDA approval is NOT very soon FFS! You total idiot. Read the RNSs (if you can) and then get someone to explain them to you.
The news regarding the FDA pre submission discussion - for thats' what it was - will determine via which route GDR can apply for FDA approval. Is that clear now?
No one has any idea what will be the result of those discussions but we hope - and that's all it can be at the moment - it will be to qualify for De Novo, which is far quicker and cheaper and also, as this is not a test that can in any endanger a patient, possibly allow GDR to sell AIHL sooner rather than later as there no risk involved in using the machines/tests.
Possible negative news on FDA pre submission discussions and the issue of imminent funding are what are currently holding the sp back. Personally I think the full NICE recommendation is now priced in. On having that confirmed however I expect there to be another spike (pump and dump for the day traders) but that the sp will settle back down to current levels until the two aforementioned issues are known factors. FDA could be good/bad. It's 50/50 so I don't see investors piling in here just yet.
Bon weekend all.
The company has told the market it will need to raise funds.