RE:Last NR I appreciate your frustration, Moonball, but both the finalization of studies and the rate at which the FDA reviews the submission are completely out of Rob's hands. It was his perception and wish that both would be done before Christmas based on his most recent interview. He recognized that an FDA EUA would be tight coming in before Christmas. That is unlikely but this is where Ridge Global may have a role to play.
I did some research trying to find out a little more about the testing. The women provided as contacts have impeccable backgrounds as do the facilities they are a part of. In their overview, as outlined on clinicaltrials.gov, they required 300 participants. They also required samples to do their cross reactivity studies. While this added some complications and while their is no way of knowing I expect the studies are completed.
With only two rapid antigen tests receiving an FDA EUA in the last two months and the demand high and supply low I would expect the FDA would be pushed to make a decision. Like you I wish it had happened already. I'm optimistic it could still happen this week.
Cherrs!!!
moonball32 wrote: I re-read the last one and it says the company is finalizing with their partners the clinical study to submit to the FDA. In reality it could be weeks before the FDA gets around to approval. At this point we don't even know if the study results have been submitted. Rob has promised before completion dates and missed the mark, by now this should not be reoccurring. Finalizing the study and submitting the results is totally within the company's control, no more excuses. I get he FDA is completely out of his control, so enough already, get the damn study submitted and let the investment community know !