Feuerstein mentioned that Amarin, “is expected to hear soon on an appeal to a top official at the FDA requesting a reversal of the Special Protocol Assessment (SPA) covering the phase 3 'ANCHOR' study of its prescription fish-oil pill Vascepa.”
Two previous "ANCHOR" SPA appeals were denied at the lower level (the review division). What appears to make the investment/trade thesis different this time is that John Jenkins, the head of the FDA's Office of New Drugs, and Amarin will get a final decision regarding the SPA for the ANCHOR study (according to the CEO of Amarin) by early August from Jenkins himself.
Assuming the SPA for ANCHOR is approved, the stock may move higher on that alone, according to Feuerstein, but the downside may also be limited because investors had low expectations of getting an SPA approved.
Feurstein also mentioned that SPA approval is not zero percent, because of some key qualitative factors:
"Everyone -- doctors, patients, the FDA and investors -- want to know if triglyceride-lowering, prescription-grade fish oil reduces the risk of heart attacks and other cardiovascular events. The REDUCE-IT study will give us an answer, if Amarin finishes the study. Re-instating the ANCHOR SPA doesn't have to mean FDA grants full approval to an expansion of the Vascepa label covering high-triglyceride patients, but it could lead to some compromise agreement which gives Amarin a little bit of what it wants while still addressing the FDA concerns raised at the October 2013 advisory panel meeting."
Shares of Amarin recently traded at $1.68, up 5.9 percent.
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