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BenK

12/04/17 1:13 PM

#46482 RE: Spumoni #46480

Trust me, I have been extremely frustrated by all the delays, and I've had to hear the complaints of friends and relatives for years that I mentioned MZEI to. I've been around since the mid-90s, and it can't happen soon enough.

But the reality is, both with the EPA and the FDA, that they could care less that this is a life-saving technology. They regard it as their duty NOT to be influenced by "emotional" appeals for a certain product because the world can't survive without it. They evaluate solely on its scientific and functional merits.

That is, UNLESS some political pressure is brought to bear, saying that a technology is critical for a national crisis or whatever. If there were, for example, an outbreak at the NHI, as there was several years ago, and Shannon called someone there who then requested a waiver from the FDA, we'd be in business.

Until something like that happens, we're still in waiting mode, at least as far as the regulators are concerned.