So there is not an EUA yet for this new test? re"These results have been included in the company's Emergency Use Authorization submission to the U.S. Food and Drug Administration."
It appears they are giving up on the China test? No wonder the stock is not popping on this NEWS..
I don't think they've given up on the other tests- it's two different tests here. A insta-result anti body test was the first.
This Pinnacle test is akin to the "swab tests" scene EVERYWHERE in the news, but who's results take DAYS to get back and now Pinnacle says "we can give the result(s) on the spot in 15 minutes" = HUGE potential !
Pinnacle is a REAL DEAL company - not fly by night bullshit or anything. They do produce leading colon cancer screening and other legit tests.
I think AYTU has "PR fatigue" as there is just a lot of noise and uncertainty to the way Josh is handling this stuff, let alone that the markets went in the sewer EXACTLY when they announced this, with too many unknowns in the PR for anyone to grasp the revenue potential to AYTU, etc.
Josh needs to get down to DOLLARS AND CENTS and cash and numbers- not "distribution agreement" PR's. HOW MANY UNITS WE EXPECT TO DISTRIBUTE IN THE COMING 6 MONTHS at X cost per unit blah blah.
Time for Josh to learn the PR game and get off the dime- he's not handled these PR's well, after an initial slew of hype PR's leading to uncertainty and confusion new IMO.
THIS is a totally new, totally different kind of test- it "might" be a damn grand slam w/ 15 minute results in its category. BUT, they need to get the FDA approval and get real "numbers of units shipped and sold" numbers - or it's just too vague is what I see as to the "no bounce" effect.
Looks pretty damn impressive- THIS could be a BIG DEAL IMO.
"Pinnacle covID RAD Rapid Antigen Test
$ 999.99 At a glance: The Pinnacle covID RAD rapid antigen test contains 25 test cassettes, buffer solution, swabs, extraction tubes and dropper tips, package insert and quick reference guide for sample collection and results interpretation. The test is performed using a nasal (nasopharyngeal) swab with no additional equipment. For Professional Use Only. For In Vitro Diagnostic Use Only. Ships September 10, 2020. For questions or ordering information, call 1-877-465-0826. "
AND
"The rapid SARS CoV-2 Antigen test
The Pinnacle Cov-ID RAD Rapid Antigen Detection Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2 in nasopharyngeal specimen (NP) from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests, or by similarly qualified non-U.S. laboratories and as applicable, Point of Care (POC) testing. "
AND
"The Pinnacle covID RAD Rapid Antigen Detection test uses a disposable swab (included) to aid in the detection of novel Coronavirus with 85%¹ sensitivity and ~99%² specificity in 15 minutes or less. Rapid antigen testing has been thought of as the missing link in the fight against Coronavirus, because antibody tests detect active and prior infections. In asymptotic individuals, they may have contracted SARS-CoV2 up to 90 days prior to diagnosis, and are effectively "cured". With an antigen test, providers can be sure positive results are indicative of a current infection, because once the infection is gone, the antigen disappears."
It's real and AYTU is a distributor now- "EXCLUSIVE" distributor, we don't know ????
The Pinnacle "home colon cancer" screening test is the biggest selling in America and a big EU market too - so they know what the hell they're doing it seems to me: