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DewDiligence

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DewDiligence

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Re: mouton29 post# 10676

Thursday, 05/08/2008 3:32:09 PM

Thursday, May 08, 2008 3:32:09 PM

Post# of 19309
Here are Dr. Cox’s exact words vis-à-vis an advisory panel:

“We are planning for an advisory panel meeting
late this year as part of this review, as is the
normal course of business for the FDA with
products derived from new technology.”

In order to give an effective presentation, GTC has to plan for a panel well in advance of hearing that a panel will actually be convened.

If the FDA considers ATryn an NME, a panel meeting is all but assured because the FDA’s latest guidelines state that NME’s should be reviewed by a panel.

Even if the FDA does not consider ATryn an NME, a panel makes sense on account of the novel production technology.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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