RE: MHRA29 Dec 2020 09:40
Be clear, the "regulatory" part of the RNS today, i.e. the bit they were required to inform the market, is that a contract term in the RTC supply agreement with the government has failed to be met. This is the news that is price sensitive, and why they (ABI in this instance) were required to announce the first day the markets opened after the key date was missed (25th dec). As I've said previously, ABI listing on AIM is great for ODX, as prior to this, RTC major news was under NDA until ABI saw fit to release it. Now they are a listed company, news flow +ve and -ve is regulated. There is no longer a possible situation that ODX shareholders can think that the RTC has secret unannounced orders, as ABI is now regulated to announce such things.
"Abingdon continues to work constructively MHRA to try to enable such authorisation. "
"try to achieve", sounds extremely wishy-washy, and doesn't sound at all confident. Why not "continues to work to achieve the necessary authorisation"
The rest of the RNS is non-regulatory and just filler in an attempt to lessen the blow. The CE requirement for the EU is exactly the same 1st jan than at 31st of dec, so its no news that the test still has CE approval for professional use in the EU, applying in malta was just a rubber stamping process. and "continues to liaise with customers and regulatory authorities in other international territories" is hardly price sensitive info.
I note that in trying to soften the blow, there is not one mention of a "hand-in-hand" association between the antibody test and the OX/AZ vaccine. Mentioning the news reports that the vaccine is liable to be authorised in the coming days and thus an automatic requirement for their antibody test is immient, would have been an obvious way of reassurance if such a tight association exists. Its becoming increasing clear than there is no such association, tight or otherwise, except in the minds of those that want it to exist.
It may well be that DHSC uses the RTC test in its thus far authorised fashion, i.e. professional use. It may well be that MHRA approval for home use is granted, although the wording of todays RNS doesn't sound as if ABI is really expecting it any more.
It may also be a case that given the negative press that the RTC has gotten from Deeks and the Good Law project (the only press that RTC has gotten in many many months) it may be deemed that politically it is seen better to just use the missed date as an opportunity.
The next key metric in this regard , is when we hear whether that 200K min ongoing reserved capacity for RTC antibody test production is ever/still being used for said test. You'd expect that the capacity expansion plans would need adjusting a little if a presumed on-going 200K a week doesn't materialised.
And personally I think it would be an absolute marketing nightmare for them if the UK government who commissioned the test, and can get it for a bargain basement price, decided not to use i