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Re: mrmainstreet post# 30988

Tuesday, 07/22/2014 4:59:08 PM

Tuesday, July 22, 2014 4:59:08 PM

Post# of 428969
Probably what we get from the FDA, regarding the SPA appeal next month.

Dear John <---- please insert your company name,

We have determined that the decision made at the lower levels, must stand, SPA status remains as is. Our staff are highly competent at making these kinds of decisions, we hate to turn around decisions! because it would involve to much work. Nothing to do with common sense or science. Dr. Mark Parks said, we should not change any questions during the meeting, it's to complicated for our ADCOM members. So we need to stick by her word, hell she threw a bunch of numbers on a piece of paper. I believe she called them statistics, that showed lowering trigs don't do anything, even though the trials didn't enroll patients with high triglycerides, I made a note on my hand, don't remember why. I started to read the numbers, I practically fainted! Don't like numbers. So be on your way, just go ahead and fill out the next form, refile your appeal to the next level.

Sincerely,
Dr. Jenkins 'Jinky'

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