Myrl Jeffcoat myrlj@jps

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3 mai, 2005 01:47

FDA Hearing/Dr. Manno's "tough luck" statement

Thanks to Pam Dowd for sending this amazing, outrageous comment from Dr. Manno, at the FDA Hearings - April 2005.

This response was given when the panel gave their reasons for their votes.

http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t3.htm

CHAIRMAN CHOTI: Dr. Manno?

DR. MANNO: I wish I had said that. I voted yes much based on many of the things that Dr. Li commented on, and I think that given the testimony here, etcetera, from the public and what I heard from the public the last time, if the doctors and the company provide the information, I think we have got enough to approve this and that the recipients of the device will have a choice. And it isn't to have a choice, they can make a choice and it's tough luck if it doesn't work. (There was a long pause here as the audience responded audibly to this statement.) No, I don't mean that. I would like that stricken. No, I believe it will work, I think, based on what I have seen here and, please, I did not mean that the way it sounded.