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Biobillionair

10/20/13 12:30 PM

#18348 RE: go seek #18346

FDA Director of CDER 2, he was at the Ad Com.

Looking at the SPA guidance I do believe he would be making the decision to break the SPA.

1)Director of CDER 2

301-796-2310
email curtis.rosebraugh@fda.hhs.gov
organization DHHS/FDA/CDER/OMPT/CDER/OND/ODEII
fax 301-796-9717
building WO22
room 3214
station Silver Spring MD 20993-0002

2)CDER Ombudsman
I have her contact information, and I'm trying to set a meeting with her, we have had dialogue for over a year r/t NCE

3)CDER Policy & Legal

I'm willing to covey our message to CDER Ombudsman.

Please advise.

Williams