Amarin Corp Plc (AMRN)

[Atom0aks]

Why aren't you waiting for another 'primary prevention trial to prove it'.

I think you're confusing on-label and off-label drug use.

Prescribing of Vascepa by cardiologymd as you pointed out in your last post,

I take it that you didn't have a CV event, therefore you are taking it for primary prevention for YOURSELF.

is called off-label drug use (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/) and is not only acceptable practice but Amarin also won the right to market Vascepa for off-label use in 2016 (https://investor.amarincorp.com/news-releases/news-release-details/amarins-right-promote-vascepar-label-affirmed-under-first).

This scenario is different from Amarin's current controversy. As was discussed during the recent AdCom,

The applicant has proposed an indication for cardiovascular risk reduction in adult patients with triglyceride levels greater than or equal to 135 mg/dL and additional risk factors for cardiovascular disease (CVD), without regard for age, diabetes status, or adequacy of low-density lipoprotein (LDL-C) control.

Source: https://www.fda.gov/media/132765/download

In order for Amarin to have an on-label indication, it would need to satisfy,

To comply with the general labeling requirements in 21 CFR 201.56 and 201.57, the INDICATIONS AND USAGE section must:
? Reflect the scientific evidence accurately
? Be concisely written to include the information necessary to clearly convey the use(s) for which the drug has been shown to be safe and effective
? Use terminology that is clinically relevant and scientifically valid and understandable to health care practitioners

Source: https://www.fda.gov/files/drugs/published/Indications-and-Usage-Section-of-Labeling-for-Human-Prescription-Drug-and-Biological-Products-%E2%80%94-Content-and-Format-Guidance-for-Industry.pdf

which as you pointed out in a post that was deleted, REDUCE-IT showed that Vascepa did not show a statistically significant benefit in the primary prevention population. While you are correct that,

SS was not achieved in left handed red headed women

Source: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152456296

Amarin is not asking for a label for that specific population. If they had, the FDA would have asked for primary prevention trial in that population.

Bringing it back to the issue at hand, the FDA would have been well within their means to ask for a primary prevention trial for the indication that Amarin proposed in there application, however, the agency decided to defer to an advisory committee instead.

Does that make sense?