RE:RE:RE:Therma Bright to Begin AcuVid(TM) U.S. Clinical Performance I'm hoping you're being sarcastic, midas!!! Did you actually read the NR?
It's the FDA that requested this additional testing (which is a positive development) thus it has everything to do with the FDA decision. As it says in the NR and that one can speculate from it and previous ones, the FDA has considered and reviewed all the other data ....positively. This cross reactivity testing is to make sure that other infections don't influence the reliability of AcuVid. This should be the final step to the EUA.
As it states in the NR, yes, more time in the order of a few weeks to complete the testing and present the results for a final analysis by the FDA.
This could very well be the Christmas present we've all been waiting for.
GLTY ....and GLTE ...looking forward to the results.
1518midas wrote: Does this have any bearing on the FDA decision, if so, that means we have longer to wait. increased volume suggests news soon though......