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Re: jessellivermore post# 60539

Saturday, 10/03/2015 8:37:21 PM

Saturday, October 03, 2015 8:37:21 PM

Post# of 430218
JL; Firstly, thanks again for all you bring to this board intellectually.
While I agree with your line of thinking in general, I do not see the need to reinstate the SPA. Would this mean another AdCom? Why even prolong this that much more when the sixty days they have requested is in my opinion enough time to review the new science and address concerns they might have with label language. This along with as I recall that the FDA really doesn't need an AdCom as this is not a new and unknown drug (Vasepa for the Marine indication has been on the market for a while) and they could move expeditiously to an approval and expansion of the label. I would think that Amarins legal team would want to move as expediently as possible. Maybe I could understand the SPA if that wrong needed to be righted from some legal standpoint but other than that why bother. I don't wish to rush the best outcome for us but on the other hand I don't want unnecessary time wasted.
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