RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA Agreed Nails, that's what bothers me about this NR. It's sloppy. If they focused on the US, defined the market like they have, but provided the material to the FDA and would've been approved by now, this thing would be flying. So I ask, why are we in the position we are? I struggle to get answers when I do "DD" because it's the same rhetoric.... phlebotomists, telehealth... but how will the test L.A. be distributed? With only two lab techs, what kind of volume will they be able to handle in the lab? And why hasn't it been approved yet? The FDA is busy, yes, but this should have been approved weeks ago based on the timeframe this news came out and where we are today. It's beyond frustrating. Maybe the market doesn't have confidence in SZLS for a reason.
Nailbiter1 wrote: I don't think Canada is a prority yet. Like the cancer tests, USA first then sloppy seconds for us Canucks. Establish then expand. Canadian phamacies were probably in sight but the Rona took care of that. Unless we have a telemed platform in Canada that we don't know of.
KPOIndustries wrote: again, doesn't add up. Why are they seeking HC approval when they don't have a distribution network in Canada. They're relying on telehealth and the phlebotomists in the US. Again, doesn't make sense.
Florentina wrote: We are in discussions with the U.S. FDA and Health Canada. Upon approval, StageZero will announce when the formal testing begins and provide details on how to access the tests.