A reseller cannot get approval. The Chinese company needs to file for approval. Then distributors can sell it after. Show one place where the manufacturer of these tests is filing for FDA APPROVAL. its not needed. This is all a temporary thing for AYTU to sell these.
Ummm that is true. That is the definition of an Emergency Use. That was straight from the FDA website. Copy and pasted. It doesn't matter how well it does. I distributor cannot get final approval to sell a medication through the FDA.