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Amarin Corporation plc Message Board

cmm3rd 4 posts  |  Last Activity: Apr 18, 2015 6:46 PM Member since: Jan 25, 2005
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  • Reply to

    PROFIT POTENTIAL

    by ken_in_kenya Apr 17, 2015 12:59 AM
    cmm3rd cmm3rd Apr 18, 2015 6:46 PM Flag

    You might want to check your assumptions. Per GTHP R&R presentation Sept. 10, 2014 (see website), disposables are sold to distributors for $10 (screening) to $23 (triage) at "up to 80% margin."

    Or maybe those numbers have since changed.

    Sentiment: Buy

  • cmm3rd cmm3rd Apr 18, 2015 1:06 AM Flag

    I hope you are not serious. If you really did contact FDA, it was very unwise (and selfish) of you to have done so. Can we just let the company handle this and not do anything more that could offend someone at FDA? Please? Good grief.

  • cmm3rd cmm3rd Apr 16, 2015 3:22 PM Flag

    Amended PMA was filed in July 2014 under new CEO after meeting with FDA to review responses to questions/concerns articulated in FDA's previous action (their second) not approving the original application. In 3/26/15 cc, CEO said FDA had said the 6 month timetable for response does not apply to an amended PMA, but that action was expected soon.

    Below is excerpt (from SA transcript):

    Finally, with regard to PMA amendment for LuViva we have been told by the FDA that once a company has received the non-approvable letter which we received in September 2013 the FDA is not held to the same timeline performance standards as an initial filing, they do restart the clock but the 180 days is not a performance goal for the FDA. With that said they have missed several dates they provided to us verbally and in writing primarily due to other priorities including PMAs that were on the clock and nationwide issues that have risen including the UCLA Super Bug which also bumped our PMA amendment in their queue.

    We continue to be in contact with our consultants and FDA and have been told that review of our PMA amendment will be completed shortly. We remain hopeful that they will provide us with the path for approval.

    Fwiw, I am skeptical that today's action is driven by a leak of FDA approval, but who really knows. Yesterday's PR re additional funding and agreement re marketing in China throws a lifeline. Somebody obviously thinks the chances that the company will survive are better today than before. Great product, just need orders from countries where approved to get company through to FDA approval.

  • Reply to

    Nancy Hutson, Ph.D. - BCRX board member

    by huskys4u2 Feb 23, 2015 1:02 PM
    cmm3rd cmm3rd Feb 23, 2015 1:58 PM Flag

    Form 4 appears to indicate it was an open market purchase at $10.27 per share, not a bonus. Was there a PR or an announcement in the earnings call about a bonus?

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