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Saturday, November 27, 2021 5:41:23 PM
FDA and more precisely in the post market setting DDMAC or its biological equivalent which we all still call DDMAC, can and does constantly enforce their marketing rules even when they lose in the Supreme Court of this land which they have done more than once. This can range from a gentle slap called a Letter of Notice to a warning punch called a Warning Letter to fines and beyond. They can and do connect phrases in space and time meaning they do not have to be connected in one piece, the context is evaluated at large, although usually they do limit it to one piece. In the premarket setting they generally look the other way very early in development for everyone and in the midstage for the little guy. When you cross the line and formally enter the process they watch everyone very, very closely and penalties can include death figuratively.
If you believe DCVax is a platform technology then I say how many of those technologies are personalized immune therapy for Brain Tumors in human investigation, sponsored by the company?
The answer is one, and that is precisely how FDA sees it IMVHO. And that is a registered trademark.
It is also clearly and without dispute by the cabal of doubt casters a full page advertisement.
So they marketed that drug at ABTA which starts a clock that ticks for at most six months or there could be severe consequences IMVHO.
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