Excellent post, Vino! The simplicity of our filter (in terms of its application) plus its safety seem to be best in class re: other cytokine mitigation solutions. Throw in the fact that it actually works (if used early and consistently) and I believe our product should be a case study in what is so wrong with the FDA.
If a small start-up company has what looks like a life-saving product, even just anecdotally (though the evidence must be compelling), there should be a streamlined process to get it approved. The CE Mark process in the European Union should NOT be a swifter path than our FDA's. In short, a taxpayer funded bureacracy should be doing all it can to save the lives of taxpayers, not save the jobs of the bureaucrats...which means people in the FDA should be Advocates, Not Obstacles to medical progress.
Unfortunately, just like the IRS or the DOD, the FDA will resist change at every turn. But who knows, maybe this COVAD 19 can shake the process up, maybe the FDA can become more an advisory board and less an IRS-like regulatory fortress that keeps products like ours off the market for years.
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