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Sunday, April 12, 2015 11:56:07 AM
"To consider the SPA issue the Judge has to know the facts. cite an exact, factual statement form FDA (or from Amarin) re what was the exact reason to rescind the SPA?"
Your argument lacks directional consistency. To consider the SPA, the most important facts are the FDA agreed the the SPA in writing. The terms were "fixed" and only could be changed by mutual agreement. The FDA could only rescind (renege on) the agreement if there was a significant scientific issue. The fact the FDA, or the sponsor, or for that matter anyone on this board, could not "cite and exact factual statement from the FDA". makes it more (not less) likely a federal judge would find the FDA in error for the rescission. Hope you can understand this.
Also, I understand what biowreck is trying to say and agree with him. He is not saying Judge Moss is going to bring the SPA issue into the NCE summary. That would very likely form the basis of a successful appeal. That does not mean he is not going to know all about the SPA. Where this new knowledge ends up going forth is anyones guess, but I consider it very short sighted to think it's going nowhere. Judges as court officers do have a duty above normal citizens to report civil and criminal violations to the authorities. So far the FDA has used its authority to keep the SPA decision in its own house, protected by the FDA appeals process...which seems to me to be down right anti american.
":>) JL
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