if i read that correctly, it seems obvious that we have a 99% chance of approval. unlike a drug, a device works, works better than its rival, or doesn't work at all. and this can be tested using simple calculations and trials, usually over the course of a few weeks rather than a few years like with drugs. if you read the technicals on Nephros website, it seems like it works better. not gonna retire off my 5000 shares, but i might take a trip to the boat yard. gltya. sleep well.
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