(1) Is there any credence to the proposition that the FDA would not have accepted SNDA for anchor in the first place, if they were unprepared to grant?
Yes, from the last cc
"Let me also note at this point in time, that no other Omega-3 therapy is approved for the ANCHOR indication. The REDUCE-IT trial has an update through our cardiovascular outcome study that is substantially underway. Our enrollment continues to progress well and we have exceeded well over 4,000 patients and we currently have more than 400 sites in 11 countries enrolling patients in the study and continue acceptance to enroll to its full completion of approximately 8,000. As we previously stated, the results of the study will not be available until specified number of cardiovascular event has been observed, the timing of which is not expected in the near term. The current level of enrollment for REDUCE-IT has exceeded the requirement as outlined in our special protocol assessment agreement with the FDA for the ANCHOR indications who have been accepted, which as you know happened last month. This is yet another reason why Amarin is optimistic that the FDA will approve Vascepa from the ANCHOR indications."
(2) How certain is favorable combo result?
Very certain, also from the last cc
"In fact, Vascepa reduced triglyceride levels in the statin-treated group above and beyond statin alone of 65%. While we have not finalized next steps in development of this combination product or series of combination products, we are happy to say that we see progress in confirming the feasibility of special combination products and look forward to providing additional update in this topic by the end of the second quarter."
Note 65% above the statin alone, that's crazy ass good. "Not finalized the next steps", translation 'at this point BP doesn't want us to release any more information'. "Combination product or series of combination", did you catch that series word?
It's truly quite exciting that the only bashing naysayers can come up with is Niacin's outcome study is so bad, Anchor won't be approved. Both Niacin and Vascepa effects some of the same labs, but strong epidemiology related to both Japanese and Western science indicates it's more to do with the EPA levels.
Williams
