Amarin Corp Plc (AMRN)

[sts66]

That does not apply to PFE/HLS promoting V for COVID use in Canada, FDA guidelines don't matter, Canada's rules on off label promotion apply, whatever they are. Not sure even if FDA rules did matter P-IT results would fall under the old guidelines - note your link if from Feb 2014, before AMRN won the 1st A lawsuit, and this section is key why AMRN had to sue:

Be disseminated with the approved labeling or, in the case of a medical device reviewed under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), labeling for the indications in the product’s cleared indications for use statement, for each of the manufacturer’s products that is included in the distributed article.

ANCHOR did not meet the existing label indications of TGs > 500, and the regimen being used in P-IT is different from the MARINE and R-IT labels too - 4 g/day for 12+ weeks, vs. P-IT's 8 g/day for 3 days followed by 4 g/day for 28 days in treatment arm and 4 g/day for 60 days in the prevention arm.