Monday, March 05, 2018 9:48:11 PM
I took my second modest position with this company today, after reading the reports of the device’s first clinical tests. Of course, they are quite incomplete; but we are not dealing with a new drug, with yet unknown biochemical outcomes within the body.
Here, it’s not biochemistry. It’s external, easily quantified biophysics — well, really, just physics. That’s the realm of mechanical and electrical engineering, in this case artfully (proprietarily) applied to medical data assessment machinery.
Real story, as I see it, is this. If the machinery can work right at the start --- as reported --- yielding and recording useful patient data, there is little or nothing that will prevent full development and approval. The device puts nothing chemical or mechanical into the body; merely listens to sounds and detects pressures, etc. All physics, nothing biochemical; nothing resembling a new drug.
Therefore, I can’t imagine anything henceforth that could unexpectedly pop up and disqualify the approval of the device(s). The facility and convenience of the machinery is clear, surpassing any hardware in use. Big market; awaiting FDA approval.
Please tell. Any foreseeable reasons these first positive clinical outcomes won’t continue, all the way to prompt FDA approval? I see none.
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