JL,
The first point of view is not the cost of appeal. Is it meaningful or not? What (and when) could be gained?
What? – Reinstate the SPA. Chance: max. 50%
Timing: FDA rescinded the SPA within 8 months after sNDA submission
Reason of rescission: Not enough evidence about efficacy
AdCom: "Do you believe (true or false) Vascepa’s beneficial effects on the studied lipid/lipoprotein parameters (ANCHOR) are sufficient enough to grant approval for co-administration with statin therapy for treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?" - "Do you believe beneficial effects on surrogate endpoints are sufficient enough to grant approval for co-administration with statin therapy for treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent without outcome study? Do we have approve something based on unvalidated surrogate endpoints?"
When? – At least 1 round of court, however it’s 99,9% sure that if necessary FDA will appeal, so we could calculate with at least 2 rounds.
The case could be filed in Q2/Q3 2015 as the earliest and the District Court phase could take 2 years (as usual) – first ruling mid-2017. If the ruling in favor of AMRN, FDA will appeal and it will take additional 1-2 years.
Result:
1.) No reinstatement – Useless action
2.) Reinstatement of SPA in 2019 – Useless action
For a good business decision you have to check all possible scenario, not the positive(s) only. All of your scenario (1-3) are possible, however if none of them exist, it is still useless, not important option to continue the appeal: they could not gain anything
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