Therma Bright Inc V.THRM

EUA FDA

[Realtor]

Have Therma Bright submited yet 

yes or non ?

Simple question

[stockmonster6]

Last update from ThermAdmin said they have not yet submitted.

[Knewbie]

Yes!  Since July 2021, our team has worked diligently with FDA officials, doctors and scientists in our pursuit to meet all the EUA requirements. It’s our belief we have achieved all requests and requirements, and have one of the most tested pre-EUA COVID-19 rapid antigen tests for submission. Once our final FDA EUA application for Point-of Care is complete, we will submit and patiently await

[spygate]

well you see what you want to see but it states we 'will' submit not we 'have' submitted so you really cannot say they have.You can hope all ypu want but at no point have they ever stated difinitively that they have sumitted their completed application...facts are facts

[Knewbie]

Read it again. It says when we have all data entered we will  submit! They can’t “have” submitted without all data entered first. 

[spygate]

your understanding on verbiage is peculiar...but hey, to each their own. What either one of us or anyone else on this board for that matter is irrelevant...facts show that they have not stated that they have submitted final application, and the SP doesnt lie

[Newcastle]

Therma will put a PR when submitted. The reason for the lenghty delivery is that, unlike any other vendor, they have been asked to do hundreds of "reactivity" studies and tests on other variations and pathogens. This will be the first "Savliva Only" Test. Last summer the FDA put out a bulliten that their belief is the best way forward was with a saliva based antigen test. If a

[Bedaine]

Good post. I like your reasoning...hope you're right