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Biobillionair

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Biobillionair

Re: yellow_bluff post# 7052

Friday, 05/24/2013 3:48:39 PM

Friday, May 24, 2013 3:48:39 PM

Post# of 426184
If the FDA intends to not follow the binding SPA agreements: 1) The director must document it in writing and provide it to the sponser 2)The sponser is given a chance for a meeting with the director to discuss the scientific issue.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf

Page 10, but read the entire document. All Anchor data has already been review and can be found under the Marine review documents.

Anchor will be approved on or before December 20th PDUFA.
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