Amarin Corp Plc (AMRN)

[HDGabor]

sts66 & BioChica

sts66,

the AC essentially led to the SPA being rescinded,

It just looks like but not true. FDA does not have to ask AC regarding ‘substantial scientific issue essential to determining the safety or efficacy of the drug‘. FDA presented as this is the ‘fact’, wording the question as the answer could be no only. But the AC did not discussed it or the ANCHOR sNDA. They discussed the R-IT sNDA.

The determination and the rescission are two different step.

FDA informed AMRN about the rescission as first step. However, 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 – NOT HAPPENED
(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 – ITS HAPPENED AFTER THE RESCISSION ONLY

SPA was / is about TG reduction, so they do not need anything to determining the efficacy of the drug and PDUFA Goals Letter mention the safety only.

The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.

BioChica,

I doubt Thero know's the triglyceride mean number, he just tossing numbers around

C’mon man, do not be silly.

’Sponsor involvement in an open part of the DMC meeting, during which data such as enrollment, compliance, and event rates may be viewed in aggregate but not separately by study arm’