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anaramos

10/13/13 7:52 AM

#16665 RE: zumantu #16661

Hello,

I am looking for experts' collaboration to write a linguistic report to the FDA showing manipulation.

I am a linguist expert in validation and adaptation of international and pharmaceutical studies as well as a pharmaceutical translator of protocols and expert's reports from English into Spanish.

I have read all the briefing documents and what I have seen is partiality in the speech. For example, how can following sentence be written as negative with the words "however" and "negative" when it is showing positive results? Or am I wrong?

"For HDL-C and Apo A-I, VASCEPA, especially 4 g dose, however, showed negative efficacy when compared with placebo"

In my opinion, this is clearly indicative of manipulation and would definitely mislead those members of panel who are not experts in the area.

My level of comprehension is not the one of a science expert, so I am asking for your help to find more of these examples so that I can write and send a linguistic report to the FDA that will show this manipulation.

Please, feel free to write me privately at: anaFDA@zippymail.info

go seek

10/13/13 7:53 AM

#16666 RE: zumantu #16661

Excellent zumantu...
Great work!

Chabojilo

10/13/13 9:57 AM

#16680 RE: zumantu #16661

Excellent work Zumantu, this should be read publicly at the AdCom, have to get someone to get in in the open mike session for individuals to make a statement to read this.

hornettt

10/13/13 11:28 AM

#16694 RE: zumantu #16661

zumantu - very, very well written.

Concise and straight to the heart of the matter.

Thank you for your taking the time and effort to go to bat for all of us that are long and sincerely believe in the science.

Best of Wealth