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Amarin Corporation plc Message Board

  • antifraudcommission antifraudcommission Sep 28, 2013 5:41 PM Flag

    Government Shutdown can Screw Us!

    A lot of investment resources are downlplaying the effect on stocks and investments if a shutdown occurs. This is all fine and good for the "general public" with an average stock (with nothing much happening).

    For Amarin (AMRN) investors, we are getting hit directly in the stones.

    The dates could not be worse if you were hoping for an run-up to ADCOM.

    The dates could destroy you if you were gambling on October/November/December CALLS.

    Uncertainty/Delays/Cancellations - we could get kicked in the stones by an NFL punter.

    Here's a look at the deadlines that lay ahead:

    Sept. 30 - The current continuing resolution will expire with the end of fiscal 2013. CRs are temporary measures passed when lawmakers can't agree on full appropriations bill.

    Oct. 1 - The start of fiscal 2014. If a new funding measure isn't in place, government workers could find themselves furloughed. In the past, furloughed workers would be repaid for their days of unpaid leave, but there's no guarantee that would happen again. Critical government services would remain open but many other agencies would close until an agreement can be reached.

    Oct. 18 - Analysis project this is the earliest the government will hit its debt ceiling and default on obligations. The window of default runs from Oct. 18-Nov. 5. Whenever it happens, it will be up to the Treasury Department to decide what obligations are paid and military and civilians could find themselves waiting for a paycheck.

    Dec. 15 - The CR currently under on the table in the House would only fund the government through this date. After that, it's back to the drawing board.

    Dec. 16 - The start of the Congressional holiday recess.

    2014

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    • yea its going to suck, and it was so avoidable it makes me sick

    • You are FOS. AdCom will go on as scheduled on October 16 and ANCHOR PDUFA will come on or before December 20. Now it's time to put you in iggy.

      Sentiment: Strong Buy

    • Also, FDA would delay making NCE decision (Oops, I forgot)

    • What is your source of info? The government has had many shutdowns, one threatened in 2011, never did the FDA shutdown, slowdown, or threaten to do so. FDA makes a profit on drug evals, AMRN's are scheduled and paid for.

      • 1 Reply to wmjenkins3938
      • The Motley Fool sayz:

        How might that affect your portfolio? The main concern would be for companies that have a scheduled meeting with the FDA panel or an upcoming PDUFA date. Amarin (NASDAQ: AMRN ) , for instance, is scheduled to meet with the FDA's panel on Oct. 16 to discuss its supplemental new drug application for Vascepa to treat patients with high triglyceride levels (200 mg/DL to 499 mg/DL) with mixed dyslipidemia. Amarin and its shareholders are very eager for this meeting as it would expand Vascepa's potential target audience dramatically. If the government shuts down, this meeting is likely to be pushed down the road.

        Similarly, GlaxoSmithKline and Theravance (NASDAQ: THRX ) have a revolutionary inhaler to treat COPD known as Anoro Ellipta with a PDUFA date of Dec. 18 (i.e., a date where the FDA either approves or rejects the drug or device in question). Just two weeks earlier, the FDA panel voted in favor of recommending Anoro Ellipta for approval by a vote of 11-2, noting that its safety and efficacy data demonstrated substantial evidence for approval as a once-daily, long-term maintenance bronchodilator therapy.

        Like Amarin, there will be no PDUFA date if the government shuts down. This would be bad news for biopharmaceutical companies and the patients who need these therapies.

        This other writer sums it up nicely too:

        So what happens at the FDA in the event of a government shutdown next Tuesday? For now, the agency isn't saying, referring reporters to an OMB statement guiding government agencies to prepare to execute "an orderly shutdown."

        But the FDA has been here before and agency watchers are referring to some of the old guidelines to prepare for what may--or may not--be about to happen. For drug developers in particular, it seems clear that a government shutdown would delay PDUFA dates for any companies looking to get a near-term approval. FDA panel reviews for drugs under regulatory review are also likely to get pushed back.

    • ha ha ha and the entire world will explode

 
AMRN
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