Can FDA approve sNDA without requiring DDI studies?
Think about this from the agency's POV. You are on public record as raising concerns over the use of mineral oil in ANCHOR, and the potential for it to have inhibited statins (at least). Other KoLs chimed in with the same concerns in follow up publications. You did not approve the ANCHOR indication, not necessarily because the study data were confounded (that is an open question, which was not resolved), but because there was no longer confidence that a reduction in TG levels was a reliable surrogate endpoint for a reduction in ASCVD, and even less confidence in any other surrogate endpoints relevant to Vascepa (such as EPA/AA ratio, etc.).
What is the only way you can be sure the REDUCE-IT data are reliable/interpretable? Request clinical drug interaction studies to be conducted by the sponsor before approving the efficacy supplement. How can the agency responsibly do anything else?
It isn't as if you cannot go on Amazon and get what in every way is bioequivalent or better to Vascepa. There are two high-purity ethyl ester EPA brands with third-party CoAs that show extremely low TOTOX scores and even over 500 mg EPA per "500 mg" capsule, and two high-purity rTG supplements that also have third-party CoAs, showing equally low TOTOX scores and stated or better levels of EPA per cap. And all four brands contain only trace quantities of other fatty acids (DHA, DPA, etc.). One of the major issues here is whether or not FDA thinks (thinks, not states) that the Vascepa API can or cannot be acquired by an at-risk patient OTC. And we are absolutely confident they do think it is accessible to the public, for much cheaper, OTC. Not to mention that Vascepa can also be prescribed off-label.
FDA is made up of highly rational, scientifically-minded people. Although of course the REDUCE-IT data qualified the efficacy supplement for Priority Review, we are confident the FDA knows this isn't some rare molecule they need to rush approval of for the public's well-being. Notice the lack of communication, and no word of expedited review? (expedited review is not priority review, by the way)
The outcome that makes sense to us is for the FDA to require additional data (blood pressure data?), causing a major amendment to the sNDA and a resultant extension to the PDUFA date of 3 months or longer, and/or holding an AdComm, and asking specifically about DDI studies. And ultimately requiring that the sponsor conduct them before granting approval of the efficacy supplement to prove the study wasn't confounded. That's the only way to prove it. It is necessary, in our view.
Yet, there are these high AUM firms actively invested here, some with an unconventionally high percent of that AUM allocated to AMRN (see Consonance, for example). Here it is with a $6B+ market cap while so many dangers to the company lurk (including patent litigation not likely to end in Amarin's favor). We think you are witnessing an extreme disconnect between speculative market value and reality, a reality not easily discernable without multi-disciplinary expertise collaboratively focused on extensive analyses of the Company, such as the services we offer. The only obvious red-flag here is that retail owns over 50% of the float.
Regards,
-MRC
AI
