Final thoughts before word on FDA EUA, HC or other info… All I can say, this stock will probably hover at $0.14-0.15 until either (1) HC approval/rejection gets announced, (2) FDA EUA authorization/rejection gets announced, (3) an AcuVid sale or (4) next Quarterly MD&A gets posted with the 2500 Venowave sales $$$. Could be a week, 2 weeks, 2 months.
I’m waiting and HOLDING… and tuning out the noise of Rob’s salary, little to no sale.
Funny no one really attacks AcuVid scientific data, just projects FDA and HC will reject, even though they have definitely proven they have met and exceeded all criteria, including the important PPA and NPA numbers, both nasal and mouth borne cross reactivity and interference tests.
Of the last 2 FDA EUA test authorized - Watmind (#30 manufacturer) and Genabio (#31 manufacturer) the “Genabio COVID-19 Rapid Self-Test Kit” sampled only 72 people (https://www.fda.gov/media/159833/download). Sure they got 92% PPA. However, THRM’s AcuVid sample over 490 (Brazil PPA 85.71%) and USA (over the reported 80.3% PPA). Idiots here attack the sample size, but the next largest to THRM’s 490+ with big pre FDA EUA submission sample size was Abbott at 460. ( https://www.fda.gov/media/141570/download ).
DiaSorin used sample size of 399 combined USA & European samples. Check out their IFU and clinical study (https://www.fda.gov/media/147311/download)
Per DiaSorin’s IFU - page 9 of 13: “The clinical performance of the (DiaSorin’s) LIAISON® SARS-CoV-2 Ag test was evaluated with a total of 399 anterior nasal swab samples collected between April 2021 and June 2021 from individual subjects during the COVID-19 pandemic. Specimens were collected from 2 different vendors (in the US) and 2 clinical centers (in Europe) from symptomatic patients suspected of COVID- 19.”
So precedents tells me FDA has to consider Brazil info, as a backing to USA clinical. Can’t wait to see AcuVid’s IFU
And … word to the wise investor. Look at the data, do your own due diligence. Chose who to believe ….those who have soured on THRM or those who present data facts and still optimistic. It’s your choice not the two sides beating away at each other on this main board. … just presenting the facts …. And yes, I’m an OPTOMISTIC believer in THRM, based on data, industry and competitor facts and successes. Not caring about Rob’s salary, slow but growing revenues on Venowave. I’m optomistic simly on the facts and data of AcuVid and no one here has presented any facts or data that shows it doesn’t meet FDA EUA or HC requirements.