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Simpsonly

11/06/14 3:33 PM

#43513 RE: uksausage #43506

Hi Sausage - the meeting referred to is the May 21st 2013 meeting the FDA called - is this not all old material?
Meeting May 21 2013
Proposed Order Feb 21 2014
Public Comments requested by May 21 2014
Those comments reviewed by June 21 2014
And here we are?

I first opined many weeks ago that the delay 'may be' because the FDA is making substantial changes to the Final Rule, as compared to the Proposed Order, because they now realize there is better efficacy than first thought and absolutely no negative side-effects to PEMF/SWT, thus leaving them to quantify and draft the Special Controls and label and packaging text.
Cheers