1.) The purpose of the SPA to avoid the issues related to the adequacy (e.g., design, conduct, analysis) of the study.
2.) "That is a change in policy at the division level at FDA that resulted in rescission of our SPA agreement over a year ago. And it's a change in policy that we believe has now involved input from FDA officials at levels higher than those who have heard our appeal. Based on the FDA's repeated position in its 3 reconsideration and appeal denials, and its internal consultation with FDA officials at even higher levels, we informed the FDA that we do not intend to appeal the SPA rescission further." (2014 Q3 CC)
The last level was OND (John Jenkins). Three level above him (based on FDA org. chart):
- CDER (Janet Woodcock) - next appeal should be submitted here
- Office of Medical Products and Tobacco (Robert Califf)
- Office of Commissioner
3.) It is possible and the opposite also... is it not possible that a ruling (AMRN's favor) would give FDA additional emotion to stick to the rescission of the SPA? "Yes, acc. to the court we were wrong in case of NCE, however we have right in case of the SPA."
+ bonus question
Why do not they issue the decision regarding the sNDA?
Waiting for R-IT's result? If .. oops .. when R-IT will be successful, we need R-IT and not ANCHOR label / indication.
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