Replies to post #20000 on Amarin Corp Plc (AMRN)

[go seek]

Ex... Do u think the decision was made improperly?

[Dancing in the dark]

(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—

changing an agreement is inconsistent with rescission.
change entails modification.

rescission means no agreement exists to modify.

ps. i am not jurisprudent.

[johnking29]

FDA - "Substantial Evidence": Would be nice to see the complete and current "legal definition" of this term as it applies to the FDA to determine if it was applied correctly in Amarin's case and/or to determine if it is arguable or not...

Probably not if they wrote the definition...

This will be the crux of any Legal Action by Amarin.


Apparently this was a term that never sat well with Applicants...

http://www.fdli.org/resources/resources-order-box-detail-view/will-fda-relinquish-the-gold-standard-for-new-drug-approval-redefining-substantial-evidence-in-the-fda-modernization-act-of-1997

[jessellivermore]

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

Of course this is a contract..

":>) JL

[wmjenkins3938]

You're right, but I think you can agree both sides have an argument and a compromise at the meeting would be best for all. I don't think stating it's an agreement or a contract really matters.

[raistthemage]

Re:Easy. It is not a contract.

That will be decided in federal court (which I think will take the view that the SPA is a contract) and if the FDA thinks they can weasel out under paragraph D

The "director's of the reviewing division" provision says this

http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf

A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has
begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor
should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act). This meeting will be a Type A meeting under the PDUFA goals for meeting management.


I think it will easily come out that they did not inform Amarin immediately when they decided this. Im almost certain a court will take a dim view of the FDA blindsiding Amarin. I am however not a lawyer.