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Re: None

Sunday, 10/20/2013 12:33:29 PM

Sunday, October 20, 2013 12:33:29 PM

Post# of 425942
Correct me if I am wrong / misssed something but the FDA officialy did not reneg / avoid the SPA as of today. (In my wiev AC's BD is not official way)

If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management.

As we know none of them happened, so it is still bunding. (?)
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