Amarin Corp Plc (AMRN)

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Article about SPA's

Special Protocol Assessment, a Blessing or a Bane?

http://www.biopharmphysicians.com/special-protocol-assessment-a-blessing-or-a-bane/

It is not difficult to see why an agreed upon SPA would be desirable to have. The qualifier “agreed upon” is crucial, however, as an SPA is, in itself, nothing more than the FDA’s comments on a proposal, delivered within a 45 day time limit. An SPA can be appealing to the industry since it is sometimes difficult to get timely feedback from the agency, Once FDA has indicated it accepts the protocol, a company will assume it has a written contract with the reviewing division assuring acceptance of the proposed efficacy claim if the data fit the prospectively defined success criteria. This is perceived to reduce risk by eliminating the fear that a positive outcome in Phase III might not result in approval if the trial design is not acceptable to FDA. Obviously that kind of risk minimization is alluring to analysts and board members. But, as always in life, things are not as straightforward as they may seem on first glance.

I suppose the court case will decide whether the SPA is in fact a contract, as I don't think this question has come up in a court of law before. But given its formality and the huge investment of capital involved I can't imagine (barring foul play) it ruling that it is not.