Wednesday, November 19, 2014 12:31:32 PM
These clowns have it arse backwards. There's no evidence they ever presented an investigation plan per section 812.25 of CFR Title 21. No evidence a IDE was ever filed. That would have to be completed before any EUA.
There is also the small problem GWPC has no R&D, or manufacturing capability (including agreements) for such a device.
Shall we once again review the history via the
Sticky
One has Whole Health pretending to be a diagnostic device manufacturer. When in reality it is a distributor via the Canadian Diva company acquisition. We still don't know the past revenues for the Canadian Diva's company, if any. GWPC still hasn't filed the 8K for this material event. They will have to cover it in the forthcoming 10K - assuming they don't chicken out, and forget to file the 10K.
What else happened on 17-Nov, the date of the PR? The Dr taken to Nebraska for treatment died. The GWPC insiders are really sick puppies pumping out a PR on that date. All they need to do now is claim they have FDA approval for a device with no prior IDE application. That will be reported to the FDA. How about placing a Whole Health logo on the next picture, instead of having a device with no manufacturer label on it? That would also be reported to the FDA. Then after the FDA reacts, it will be SEC time. Some of these microcap pumps are just too lame.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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