The Key Piece.......of the December 16, 2021 NR is part of the following:
ln response to section lV of the recent Policy for Coronavirus Disease-Z0l9 Tests During the Public Health Emergency (Revised): Guidance for Developers and Food and Drug Administration Staff / issued on November 15, 2021 ,the Company entered into an agreement with a contract manufacturing firm with capabilities to deliver a minimum of 500,000 tests per week.
Per the new guidance:
"Specifically, at this stage of the pandemic, the FDA intends to focus its review on EUA requests for the following types of tests; Diagnostic tests (molecular and antigen) that can be used at the POC or completely at home, from developers who have indicated the abilityto scale up manufacturing capacityto 500,000 tests per week within 3 months of authorization."
THRM clearly did not have this capacity with the other 3 companies they had already entered into agreements with. Presumably this company can do so and probably a lot faster than the 3 month requirement.
The other important part of this announcement is that there is no logical or financial or investment incentive for Rob to not only enter into this agreement but also present it as NR worthy if he was not absolutely confident AcuVid was going to pass this final hurdle to FDA EUA. The fact that is even been touted in a national newspaper lends credence to this.
Early Christmas present today???