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Steve Rosenman
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Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
  • Amarin's NCE Update 7 comments
    Jul 15, 2013 4:33 PM | about stocks: AMRN

    If you have been following my instablog, I told you NCE status update would likely be today (not this Friday), and it was.

    I am learning that FDA is likely to announce the ruling around or in direct time relation to Anchor vote in December. If so, this is a favorable indication for Amarin in my opinion. A 'no' could be handed down at any time. I have never been a subscriber that NCE is tied to Anchor, but from a pure manpower FDA resource standpoint, that case is getting more convincing and there have been some attorneys close to the matter suggesting this. It also alludes to expected YES vote for Anchor approval, should be an easy go ahead for Anchor and we should get that nod in October from FDA panel. $20+ stock selling for singles here folks...

    Stay tuned.

    Stocks: AMRN
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Comments (7)
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  • I am unclear about whether NCE status has been updated for this month or not. The FDA Orange Book page says that is current through June 1st. On the line below, it says that the patent and generic data was updated today.
    16 Jul 2013, 12:07 AM Reply Like
  • That is because Orange Book which is when NCE get updated is once a month and patent and other general changes are daily.
    16 Jul 2013, 08:48 AM Reply Like
  • Author’s reply » The OB is updated with still no determination on AMRN.

     

    I am now convinced it is tied to Anchor, as an NME decision (if NCE a no) would not be able to be given for Marine due to Lovaza. That is not the case for Anchor. So, worst case is 3 year starting when Anchor is approved. I do, however believe as I have said before that we get NCE. An attorney very familiar with the situation contends that this is not an AMRN issue as much as it is an FDA resource and process issue. The fact that FDA would group the timing together to decide NME/NCE at time of Anchor helps to support this theory. Apparently, there has been back and forth btw AMRN and FDA on some different points, but nothing conclusive in terms of written letter determination yet.
    16 Jul 2013, 09:13 AM Reply Like
  • if correct, also lends credence to the theory that FDA is inclined to approve Anchor this year and before outcomes data. if they were to push Anchor until post Reduce IT, then they would be inclined to go ahead w their exclusivity determination now.
    16 Jul 2013, 12:03 PM Reply Like
  • Author’s reply » Let's be clear, FDA will be ready to rule in December, and outcomes data will not be a determining factor.
    16 Jul 2013, 05:03 PM Reply Like
  • Great call on the OB update. Shows that you have a few connections. Agree that NCE will not be a product of Anchor but may coincide with PDUFA decision on Anchor as well. JMO.
    16 Jul 2013, 08:53 PM Reply Like
  • Your thoughts on page B-6 aka Vascepa and NME designation?

     

    http://1.usa.gov/15iCZuA
    25 Jul 2013, 02:57 PM Reply Like
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