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Re: The Holder post# 10105

Thursday, 02/26/2009 4:39:01 PM

Thursday, February 26, 2009 4:39:01 PM

Post# of 58465
I'm very moved by your wonderful analysis and committment.

But as to the review finding, why did the committee "reaffirm a negative opinion" for approval of Genasense? There must have been something wrong with the product. What was wrong?

What has now changed that will persuade the Committee to adapt a positive opinion of the product? What data is showing up in the latest trial that apparently didn't show up in the previous trial that got Genasense shot down?

And isn't this review restricted to the European market? How does this affect the FDA's view?

And what is the "EU" that is mentioned in the Press Release that you identified?

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