Replies to post #19973 on Amarin Corp Plc (AMRN)

[exwannabe]

Since the SPA is a contract

And will most likely be found to be one in federal court... how can Amarin lose in a lawsuit???

Easy. It is not a contract, and the law that creates SPAs specifically gives the FDA the ability to do what they did:

US Code of Federal Regulations. 21 USC 355:

(C) Any agreement regarding the parameters of the design and size of clinical trials of a new drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not be changed after the testing begins, except—

(i) with the written agreement of the sponsor or applicant; or

(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.

So given this one must argue that the decision was made improperly, and not just that it is wrong, that is a tough road to hoe. And certainly there is no prima-facie argument that the FDA breached a contract.