Replies to post #201510 on Arrayit Corporation (ARYC)

[Neotide]

Pre-emergency use authorization

Web, I think the FDA did mention it was converted to a "Pre-Emergency" authorization (I'm not sure what that means exactly) but the sensitivity was not up to par and ArrayIt kept pumping it without disclosing those facts. See the clip from the DOJ complaint below:


An email obtained in this investigation that was transmitted by are presentative of the FDA to Executive-1at Arrayit on April 17,2020 stated that Arrayit’s emergency use authorization would be converted to a pre-emergency use authorization because it was missing key pieces of information that was necessary for FDA to conduct its review of the test.The email also stated that Arrayit’s test sensitivity of 85.7% in detecting those with antibodies and specificity of 88.1% in detecting those without antibodies were not at an acceptable level of performance that was necessary to obtain emergency use authorization. However, SCHENA and others nonetheless continued to promote Arrayit’s bundled COVID-19/ allergy test without disclosing these facts.

I think the real trouble comes into play when Dr Schena started to use the Strawberry/Rhubarb pie logic, or the "I know I can make a test so I'm going to start telling everyone we have a great test, because I know I can do it". This is considered misleading given the timeline below:


Mark Schena made false and misleading statements in emails to investors claiming that Arrayit had a COVID-19 test before Arrayit possessed all the essential components for such a test. Arrayit did not order the reagents for a COVID-19 test until March 17, 2020, and these reagents were not shipped to Arrayit until March 19, 2020.

Accordingly, Mark Schena’s statements to investors that Arrayit had a COVID-19 test before March 19, 2020, were false. 38.Mark Schena a ls o made false and misleading statements in emails to investors claiming that Arrayit’s COVID-19 test was pending emergency approval.

Arrayit did not apply for Emergency Use Authorization with the U.S. Food and Drug Administration (“FDA”) until April 13, 2020. Accordingly, Mark Schena’s statements to investors that Arrayit’s COVID-19 test was pending emergency approval before April 13, 2020, were false

[Alyssa]

lolol. It's right there in the esteemed U.S. Postal Inspector's Affidavit.