No, not quite, AT1 AB test (Access Bio tech) already has TGA approval (Aug2020), so it is available for purchase for Covid19 clinical or research or gov testing purposes. Not available for retail/consumer purchase as AU gov has not allowed any Covid19 test to be sold commercially (yet).
The Peter Doherty Institute review of AT1's approved test is expected in next 1-2-3mths..dunno timing as none stated.
Yes, waiting on US FDA re-approval of Access Bio test (same thing sold in AU under AT1 brand) - that should be coming any day now as its been 2mths already...and the assay test strip core is the same Access Bio RDT that the US FDA already EUAd back in June2020.
The FDA SRO list doesn't matter in any way for AT1. Think of it as a supplementary gov monitoring list - b/c FDA approves X product, companies connected to that product (either as the main or subs) stand to benefit from the US FDA approval + future sales. eg: FDA employees are prohibited from purchasing shares in SRO listed companies (b/c their org regulates these products) .
So the FDA adds any publicly trading company that substantially is part of the X product manufacturer/sale they approve/regulate (food, drugs, medical devices etc). AT1's device constitutes 50% of the Access Bio test manufacturing+has profit sharing agreement. Naturally both companies stand to benefit a lit from potential sales (or even SP spike from US FDA approval) so an FDA employee could for example buy AT1's AU shares (privately), thinking to make a some extra money on the side because they know Access Bio+AT1's test will get approval...which could potentially corrupt FDA independent processes. Hope this makes sense..its nothing to worry about for AT1's deals. We have similar regulatory lists here preventing AU TGA, gov miniterial depts etc from purchasing the stuff they are supposed to be monitoring..
AT1 Price at posting:
36.5¢ Sentiment: Buy Disclosure: Held
