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Re: ggwpq post# 221034

Friday, 10/25/2019 10:05:43 AM

Friday, October 25, 2019 10:05:43 AM

Post# of 426287
“The Woodcock” communication is not ripe to share because there is an ongoing discussion of the FDA filing briefing materials publicly well before the Ad Com. I thought she ended the debate poorly with “we will follow our procedure”....

Her response today is to an email I sent 8 days ago...there seems to be some serious reconsiderations regard the above procedure.

As far as pissing off Woodcock, that’s BS, she’s the most experienced professional regulator in Washington DC; there’s not a harder working more respected Director in ANY US branch of government. I am having an honest and open discussion regarding improving a broken drug approval system and she knows this.

BB

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