Amarin Corp Plc (AMRN)

[HDGabor]

R-IT is the trial to prove the intended ANCHOR label! There is no sNDA tied to R-IT.

It will not happen, but if (theoretically) ANCHOR will be approved it will contains "Limitations of Use: The effect of VASCEPA on cardiovascular mortality and morbidity in patients with mixed dyslipidemia has not been determined."

R-IT is the trial to delete this Limitation of Use. sNDA will be submitted after the end of the study, otherwise how could the FDA approve?

SPA / sNDA

SPA is not mandatory for sNDA submission. Any study could be done without SPA and the sponsor could submit the sNDA. (The PDUFA goals for special protocol assessment and agreement provide that, upon request sNDA FDA will evaluate within 45 days certain protocols and issues ...)

If SPA is exist it is the primary basis for an efficacy claim. If not (never signed or rescinded) FDA could evaluate the claim based on "anything / everything".

I hope (and think) they are not continuing the appeal and "force" FDA to issue the decision regarding the sNDA. The CRL is possible, but not the one and only scenario. FDA definitely not will accept the claim (sNDA) as it was submitted, but the label could be negotiated and hopefully it will includes at least the ANCHOR study data and if "we are lucky" some modification of the Indications and Usage.

May you could accept the rationale?