Therma Bright Inc V.THRM

Additional Testing

[Smokey1958]

Hopefully the IRB approval and the securing of test sites will kill two birds with one stone. This additional testing could be carried out to satisfy the requirements for applying for approval for at home testing (as per the NRs) as well as fulfilling the requirements for cross reactivity testing (as expressed in the recent interview with Rob). 

Most companies applied for FDA EUA for the use of their tests in a lab, clinical or health practitioner setting ...and then applied separately for at home use. That is one of the reasons you see the same company with the same test more than once on the FDA EUA list. Any modification to the test or it's method or site of use required a separate application. It appears Rob wants to or is being encouraged to do it all at once ....by the FDA??? That, imho, is an incredibly positive development.

Let's go Therma Bright ....the anticipation is bubbling!

Have a great weekend everyone!!!

[Trueblood]

I believe that the FDA has verified the validity of Thermas test this is validation of its clinical functionality. The last hurdle to FDA approval which should come before the end of the month. Not much of a NR as approval of the sits was a given and was only to take a few days not two weeks. Would have liked to see a better pop but can wait.  All said better than Sona that halted trading for

[BUYSELL101]

I agree with you TRUBLOOD 

[hemi3tc]

FDA is waiting for data from the US clinical trials. FDA does not accept data from other countries even from big pharma like Roche or litlle Sona who did theirs in Saudi Arabia. some companies just try to save money to confirm something works b4 spending big bucks on US clinical trials.