Therma Bright Inc V.THRM

almost there just a few more sleep

[idunnoyou]

FDA approval on medical devices usually takes no more than 90 days (as per FDA website) to make a final decision, not sure if that number is business or regular days, or if that is from submission date or letter of acknowledgement.

Eitherway, we are about 37 business days into the FDA process from July 23rd, 2021 and have the advantage of Emergency Approval. Hang tight, it is getting close.

FDA submission - July 23, 2021

https://www.thermabright.com/.../therma-bright-awaits.../

Additional details were submitted to the FDA on September 1st, 2021

https://www.thermabright.com/.../therma-bright-provides.../

https://youtu.be/lxtAq76-pk8

[TheeRook]

 If THRM file with the FDA then they must have given the data for the Limit of Detection.   Why does THRM not publicly pucblish the LoD?   SONA was one for playing  games with their results had higher accuracy than the ohters yet their LoD was worst.   Which does not add up  and the final results their test was a BIG failure.

[Smokey1958]

There is absolutely no need to express the LoD as most wouldn't understand its implications anyway. In fact I don't believe that most of those public companies submitting for approval through the FDA or HC, including the most financially successful to date, Abbott Labs,, have done so in their NRs. As for SONA, I am quite sure that Therma Bright management is well aware of that debacle