What's clear is the FDA needs to clarify what's going on. This may take another law suit...but not updating Vascepa exclusivity and not providing any clarification is injurious to Amarin stakeholders. The if's and but's you propose are hurting my brain.
If OB doesn't update soon with exclusivity I'd be for Amarin stakeholders taking FDA to court for anticompetitive violations. The lack of exclusivity prevents business deals.
I understand that the H-W act provides for 5 years exclusivity from the time of FDA approval. Now my thought is that if the Watson appeal is accepted and the appeals process drags on past the NCE exclusivity time and then is settled in favor of Amarin,would not Amarin be given an updated exclusivity period? The law is not silly putty, but neither is it fixed in stone.
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