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alternatepatel

08/22/14 11:14 AM

#32692 RE: HDGabor #32691

Thanks. Never had seen that.

But.......

Something more concerning is the increased negativity in AMRN's language:

" Existing levels when the FDA have not agreed, then there can be no assurance that the appending response from the FDA will be any different. We continue to see this effort as an upcoming battle."

No hint of optimism after meeting with JJ.
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north40000

08/22/14 11:22 AM

#32694 RE: HDGabor #32691

"within 30 calendar days from the date of the discussion" could be the next day or as long as it takes to write an opinion. What staff does JJ have to assist in writing of opinion? Or do you expect he will write it himself?