Amarin Corp Plc (AMRN)

[HDGabor]

BB-

"The Committee is aware of FDA’s ability to rescind a SPA agreement reached under section 505(b)(5)(C)(ii) of the Food, Drug, and Cosmetic Act only if it demonstrates that ‘‘a substantial scientific issue essential to determining the safety or efficacy of the product has been identified after the testing has begun.’’

This standard is informed by the Congressional Record and the 1997 PDUFA Goals Letter."

The questions are how and when.

How: Basically the drug has to be safe and effective for approval. Safety is not a question, however efficacy had not been confirmed. FDA was liberal in case of lipid-altering drugs and granted approval based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes. BUT: we could not forget that this approach was FDA own decision, it was not required or granted by any law. FDA changed their mind and request efficacy proof. They are not breach any law by this, just raise the bar for the law level.

As the law require proof for effectiveness, I do not think that FDA will be penalized (charged) for the rescission itself.

HOWEVER (when)

FDA was aware of the uncertainty at the date of pre-IND meeting / SPA / sNDA's submission, etc. (and especially when the result of AIM- / ACCORD- / HPS2- became available), but they did not do anything till end of October 2014.

If the Committee could instruct the FDA I could imagine the following scenario:
- reverse the rescission due to technical error (but definitely not for scientific error)
- request a compromised / partial approval
- leave it as it is and notice FDA to avoid this type (late) action in the future

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I do not think that AMRN has a chance for any financial compensation, but if yes it could be for unnecessary expenses (ie.: cost of sales staff & marketing) and not for unrealized revenue.