RE: FDA pre submission15 Feb 2023 14:35
there was an RNS on 5th Oct specifically detailing all of this. Worth a read.
In the audited results RNS mention was made of the FDA approval being sought:
'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'
They see 'HUGE POTENTIAL..' So do I. Hence for me news on this is even bigger than NICE news coming at end of March. Most expect that to be good so is effectively priced in already. As I keep saying, the only thing holding back the sp at the moment is the funding issue. Not sure it's realistic they will drop Development costs from £250k per month to £50k so whilst they can make a saving I suspect it's not that much. Hopefully the cash runway is good up to the end of July or maybe even August.
Just one bit of good news and we're off to the races. Any NHS Trusts committing to adoption of AIHL, news of any successful GRANT applications, FDA news confirming De Novo route, funding issue sorted via a short term loan or outside sponsorship, a jv partner coming on board, a bid to buy GDR. Any of those and we're well above 30 if not 40p. Ironically the one piece of news I think won't now impact the ps greatly is NICE confirmation at the end of March for reasons stated above. It's expected to confirm recommendation so is already priced in.