RE:RE:almost there just a few more sleep 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. As you have suggested, for THRM to file an application with the FDA they would have done so including the LoD. Imho it is also expressly obvious at this stage of covid and testing that they would not have submitted an application that was doomed to fail.
It would have been ridiculous for THRM to submit an application after having expressed publicly an LoD that the average investor could consider suspect. This is clearly something that has bothered you for months. Have you contacted Rob Fia on this?
Cheers!!!
TheeRook wrote: 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.
idunnoyou wrote: 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
Additional details were submitted to the FDA on September 1st, 2021