This has been their problem from the get go. It’s both.
Getting approval for a medical device is relatively easy, but Technegas is classified as a drug, and because it’s been around for so long they had to submit a whole lot of details about its properties. That was what the Complete Response was about I think.
I expect the approval will be a NDA (new drug application), but I’m not 100% sure we are monitoring the correct part of the FDA site, but suspect we are.
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