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Re: HDGabor post# 34591

Wednesday, 09/17/2014 5:31:33 PM

Wednesday, September 17, 2014 5:31:33 PM

Post# of 423945
Just downloaded the podcast and listened, came away with one big point, I'm paraphrasing what I heard below:

"We offered ANCHOR compromises (labeling?) during the last 10 months but the FDA refused to negotiate while the SPA appeal process was ongoing"

So perhaps the change in tone is due to FDA perhaps indicating allowing some sort of label change if AMRN backs off on the legal front? Meaning no ANCHOR label that mentions reductions in CV risk, but perhaps allowing just "treatment for TGs 200-500", which is what I originally thought ANCHOR was all about? Clearly the FDA were PO'd by the appeals and held the "no negotiating" sword over ARMN's head until they gave up the SPA fight - whether they have quit fighting remains to be seen, but nothing on the call indicated further appeals, which are worthless wastes of time in any case.

Perhaps there is hope for the sNDA after all, if changes are made in what they are asking for on the label? Still confused about how that is possible with no SPA though, which filing the ANCHOR sNDA was tied to.....something has apparently changed, but I have no idea what the outcome will be.....

The Thought Police: To censor and protect. Craig Bruce

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