Replies to post #46756 on Amarin Corp Plc (AMRN)

[HDGabor]

raf-

You are saying that the SPA was based on FDA's assumption that lowering trigs lowers CVD, correct?

Yes

And the reason SPA was rescinded is because that assumption proved incorrect via AIM HIGH and ACCORD LIPID STUDY?

No.
FDA did not say the assumption is incorrect (or correct). We do not have an exact explanation. Acc. to the 9/16 CC:
"...FDA stated that to approve an indication based upon triglyceride lowering in statin treated patients with triglyceride levels below 500 mgs per deciliter, it needs to be confident that triglyceride lowering will result in cardiovascular risk reduction. ...failed results of the cardiovascular outcome studies of other drugs, ..., reduced FDA's confidence in the use of triglycerides alone as a surrogate for regulatory approval of a drug focused on cardiovascular risk reduction in this population, such that the FDA would like to see outcomes data to confirm cardiovascular reduction benefit. ... FDA has revaluated the situation and has adopted a more conservative approach than previous applied for biomarker based approvals targeted towards cardiovascular risk reduction. FDA expressed to us that the accumulation of the scientific information that led FDA to conclude that HDL cholesterol could not be used as a surrogate end point for cardiovascular risk reduction occurred in the same timeframe as its decision to rescind the ANCHOR SPA agreement. FDA noted to us that this illustrates that the science related to the use of drug induced changes in lipid parameters as surrogates for cardiovascular risk reduction remains unstable and fluid."

Acc. to the ACT:
(C) (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.
(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and at which the director will document the scientific issue involved.

predicate: has been identified
subjective: by the director of the reviewing division
objective: that a substantial scientific issue essential to determining the safety or effectiveness of the drug [it is the decision itself, isn't a condition]
adverb(time): after the testing has begun

JL-
Where is the "new"?
Which is the part that means "can only be terminated on "new" substantial evidence"?
One condition exists only: the decision should be made

I do not have problem to stand corrected, but I could not see what you are saying.