Amarin Corp Plc (AMRN)

[CaptBeer]

Mineral Oil Still a pain in the Ass

Here's my letter to Amarin:

Hello,
It appears that the NICE UK Appraisal Committee is playing hardball. 1 (nice.org.uk)
It seems that the mineral oil placebo conspiracy theory has crept into the decision making process (Section 3.8). Amarin has addressed this issue many times in many forums including your FAQ pages. Dr. Bhatt himself and Dr. Budoff have separately tackled this issue.

We also know that the FDA addressed this issue at the REDUCE-IT ADCOM in November 2019. They also addressed the issue in a Citizen Petition response letter dated December 13, 2019 to Medical Research Collaborative:

From Docket No. FDA-2019-P-3424, p.9
“Data suggest that any potential Impact of Mineral Oil interaction with ASCVD Drugs did not Meaningfully Affect the Magnitude of Vascepa’s Positive Treatment-Benefit Compared to Placebo.”

Furthermore the DMC for ANCHOR?, and REDUCE-IT were instructed by the FDA to continuously monitor any clinical signals concerning placebo interference.

Thus, May I suggest that you not only reference these public statements and actions by the FDA, and the DMC in your response to NICE, but to have the FDA and the DMC supply testimony to such.