Saturday, October 31, 2015 2:19:11 PM
With BB, that there is a lot more coming down the pipe from our legal team after NCE and 1A and with JL that AMRN should not touch anything re Reduce-it.
1) I don't understand the urgency of having an earlier interim look; we are less than 6 month away from the original interim look agreed with the FDA. There is zero reasons to jeopardize the data for a 4 year old CVOT just to take a look at the data 3-6 month earlier. I know you should never say never but if it does happen, no matter the data, I will sell all my shares.
2) AMRN's legal team is top notch. They are going after the FDA with precision. They took the SPA appeal as far as they needed to, to show "good faith" in trying to resolve the issue thru the FDA's own appeal process. NCE and 1A wins were clear to all of us who followed the story for a while. I don't believe the legal team will stop with 1A...SPA fiasco is next in federal court and damages after that. IMO, the FDA is very aware of the mess they got themselves into and the FDA has no interest in settling with AMRN on 1A only, if they think they will be back in court for SPA rescindment and damages. I believe FDA/DOJ wants the AMRN case file closed and the only way to do so, is to reinstate the SPA and give Anchor indication. It has nothing to do with science...all lawyer vs lawyer and that always takes time. IMO, (from my past discussions with management) one of the sticking point of negotiations is what will happen if Reduce-it is not a success as we all think. How will the FDA be able to "take-away" the Anchor indication. I put my money on our legal team to cut us a good deal.
In the end, it all gets back to Reduce-it. Most of us who take Vascepa believe the data will be very strong so the only way we don't get paid is if a) we are all wrong or b) reduce-it gets jeopardized. That's why I truly hope they will not mess with it in any way. They need to keep it as clean as possible.
IMO
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