One other medical device company but it was not an OTC stock and it had a suite of devices so not really a good comparison. But it did get me watching the process of FDA approval for its products and its competitors products. Most of the FDA related stocks I have invested in are drug companies. Only a couple of those were on OTC and in a situation of must get FDA approval for a single drug or risk failing. I'm down to only 2 OTC stocks and then I am done with that type of investment. I'm getting too old to wait a decade or more for a start up to succeed. The two I have feel like slam dunks at this point (hope I'm not jinxing myself/us) but it has taken almost 10 years for them to get to that point :).
As for the comparison between drug and device, what they definitely have in common is that FDA gets to call the shots and the FDA is very comfortable describing what is required for approval and then adding more 'surprise' requirements in the future. A recent example for RDGL is the rabbit tests whose plan got approved last winter only to have more rabbits added this summer. FDA does the same thing with drug testing. They keep adding on new tests that they didn't mention when the company met with the 6 months ago seemingly intentionally delaying the approval. I feels its intentional because if the company had been told about the 'extra' tests in the previous meeting with the FDA they company would of gotten those tests done.
I completely agree that FDA not approving IDE at this point would be insane and also feel we are going to get it once we can get the FDA to say its ready to be submitted. I'm really hoping to get a time frame for submission from Korenko in the upcoming quarterly report.
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