RE:What I don't understand is..I dont think Sona is being dicked around at all. They have been in constant touch with the regulator and probably anticipated the new FDA template. That's why they can respond to the new requirements in 2 weeks, which is a very fast turnaround. If they didn't know of the changes, and the requirements were too difficult to meet, then it could have taken a month or more to redo (worst case) the field studies. There are far too many BS test kits out there that received EUA. Testing is now receiving negative publicity. The FDA had to do something to restore public confidence in testing. In my opinion, this works in favour of Sona. If their field studies exceed the FDA requirements, then they would have credibility. The competition will have to pass a higher bar for approval. This means less competitors to Sona. Sona will get more orders. And Sona SP goes up even more!
TheModernAge wrote: Why Sona is getting dicked around so much. They've gone the extra mile to get third party validated, and now it seems like the CROs aren't taking it seriously. We could have been approved weeks ago. I hope politics aren't coming into play here to delay a Canadian test. I hope the Saudis can quickly come through with amazing clinical results and give a major middle finger to the US lab.