You know I sometimes disagree with your windmill tilting, BB, but you're really on a good path with this one - this a a game changing new direction you're taking - wish you luck!
The excuse of rescindment was outside FDA Regulatory jurisdiction and scheme. FDA does not have the jurisdictional powers to practice medicine, a fact the courts have ruled on numerous times. The “ regulatory judgement" used by FDA to rescind SPA was not a safety or efficacy judgement, it was a medical judgement. Furthermore, this medical judgement does not meet the current standard of care.
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