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rafunrafun

10/04/14 9:25 AM

#35884 RE: ziploc_1 #35883

But based on the latest CC, JT did not say that we are pursuing further SPA appeals. Moreover he did not say what our game plan is, other than that we are not stopping REDUCE-IT. So I ask, what is our game plan, who is making the next move, are we pursuing appeals or are we waiting for FDA to rule on sNDA, and if so, don't they have unlimited time, so we could literally be waiting forever? If JT doesn't pursue appeals anymore, does he think he could reach a compromise with FDA? I would like to think so, but PPS tells otherwise.