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Arena Pharmaceuticals, Inc. Message Board

centurycom 61 posts  |  Last Activity: Jun 22, 2015 6:39 PM Member since: Apr 17, 2008
  • centurycom centurycom Jun 4, 2015 8:02 AM Flag

    Ref:
    From Louie on IHub
    UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK
    X
    AMARIN PHARMA, INC., et al.,
    15 Civ. 3588 (PAE)
    Plaintiffs,
    ORDER
    -v-
    UNITED STATES FOOD & DRUG ADMINISTRATION, et al.,
    Defendants. X IISDC SONY
    DOCUMENT ELECTRONICALLY FILED DOC #:
    DATE FILED: ef2. / ( 5

    PAUL A. ENGELMAYER, District Judge:
    On June 2, 2015, the Court received a letter from the Government, seeking an extension of the preliminary injunction briefing schedule. Dkt. 21. Plaintiffs oppose the Government's request. Dkt. 22.
    Oral argument, currently scheduled for July 7, 2015, at 9 a.m., shall proceed as scheduled. See Dkt. 14. However, to give the Government time to thoughtfully address in its brief certain regulatory guidance which it states will be issued on June 5, 2015, the Court will modify the briefing schedule as follows:
    • The Government's opposition to plaintiffs' motion for a preliminary injunction is now due June 18, 2015.
    • Plaintiffs' reply is now due June 25, 2015.
    The Court further directs the Government to file on ECF the FDA's regulatory letter by June 8, 2015.
    The Clerk is directed to terminate the motion pending at Dkt. 21.

    SIGNED....
    da judge

  • centurycom centurycom Jun 4, 2015 7:57 AM Flag

    The opposite of what is happening now.

  • Reply to

    Hmmm... sudden jump in share price

    by fsulevine Jun 3, 2015 1:35 PM
    centurycom centurycom Jun 3, 2015 7:06 PM Flag

    Chartists say the Bulls are in control:

    AMRN has risen by +25.91%.
    Market Outlook
    The bulls are in full control. The negative sentiment that led to the last bearish pattern has evaporated. Besides, the signal is suggesting to STAY LONG. It is best to follow the signal and continue to hold this security.

    Big Short holders are putting out BS stories to try to alleviate the pain, but the writing is on their balls. Watch the smart ones bail tomorrow.

  • centurycom centurycom Jun 3, 2015 6:42 PM Flag

    StephenRosenman
    $AMRN Talk about misleading investors and the media. The clinical trial on MAT9001 is an absolute joke...

    Apparently it was only a phase I trial checking bioavailability. Hehehe. Some big Shorts are desperate, so actually this is a great story for Longs.

  • Reply to

    Hmmm... sudden jump in share price

    by fsulevine Jun 3, 2015 1:35 PM
    centurycom centurycom Jun 3, 2015 5:44 PM Flag

    From Louie on IHub
    UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK
    X
    AMARIN PHARMA, INC., et al.,
    15 Civ. 3588 (PAE)
    Plaintiffs,
    ORDER
    -v-
    UNITED STATES FOOD & DRUG ADMINISTRATION, et al.,
    Defendants. X IISDC SONY
    DOCUMENT ELECTRONICALLY FILED DOC #:
    DATE FILED: ef2. / ( 5

    PAUL A. ENGELMAYER, District Judge:
    On June 2, 2015, the Court received a letter from the Government, seeking an extension of the preliminary injunction briefing schedule. Dkt. 21. Plaintiffs oppose the Government's request. Dkt. 22.
    Oral argument, currently scheduled for July 7, 2015, at 9 a.m., shall proceed as scheduled. See Dkt. 14. However, to give the Government time to thoughtfully address in its brief certain regulatory guidance which it states will be issued on June 5, 2015, the Court will modify the briefing schedule as follows:
    • The Government's opposition to plaintiffs' motion for a preliminary injunction is now due June 18, 2015.
    • Plaintiffs' reply is now due June 25, 2015.
    The Court further directs the Government to file on ECF the FDA's regulatory letter by June 8, 2015.
    The Clerk is directed to terminate the motion pending at Dkt. 21.

    SIGNED....
    da judge

  • centurycom centurycom Jun 3, 2015 2:54 AM Flag

    Sounds good. Too bad they didn't patent it and go through the expensive gov regulatory processes as Amarin did so they could make mega bucks off of it like Amarin will. Ask Mr. Grays relatives and Mr. Ma Bells to see how that is working out for the families. Oh yeah, everyone that invested early in AT&T and the Bell companies good ideas suck unless you do something about it.

  • Reply to

    FDA

    by rafunrafun Jun 2, 2015 10:52 PM
    centurycom centurycom Jun 3, 2015 2:45 AM Flag

    Sounds like he is P.O.ed because his well thought out plan ( as good as can be expected from an idiot ) is not working out.

  • Reply to

    This News Was Expected

    by invest83838 Apr 28, 2015 8:27 AM
    centurycom centurycom Jun 2, 2015 9:09 PM Flag

    If it isn't so difficult then direct all of us to the link that discloses their sale.

  • Reply to

    FDA Straw Man

    by vrlan Apr 30, 2015 10:12 AM
    centurycom centurycom Jun 2, 2015 9:03 PM Flag

    I believe the slower than expected sales are due to the label induced restrictions created by the FDA, hence Amarin's suit for free speech in an attempt to make sales off label.

  • centurycom centurycom Jun 2, 2015 7:27 PM Flag

    Seems you have a nose for picking up the trail. Very insightful. It did seem he was exercising free speech rights. Lol.

  • centurycom centurycom Jun 2, 2015 10:01 AM Flag

    Let's hope they do, especially in Amarin's case.

  • centurycom centurycom Jun 2, 2015 9:57 AM Flag

    Seems many are afraid of someone capable of bringing insightful DD to the board. Your fears merely justify his worth. Thanks.

  • centurycom centurycom Jun 2, 2015 9:04 AM Flag

    My thinking is that Amarin shouldn't have had to go to court for NCE 5 year designation, had their SPA designation cancelled, or had their label restricted. The FDA is being obstructive rather than cautious and those in charge don't seem to have a clue. I believe that all submitting new drug applications should be treated fairly and non- discrimitory, but also those drugs with a tract record, or history of safety should be more freely allowed to test their product in the market place.

  • "What's next?
    Although it's impossible to tell how long Amarin's lawsuit against the FDA will take to play out, the important issue here is the company's cash runway. In other words, will Amarin have to dilute shareholders in a major way before additional catalysts can enter the picture?

    Because of its ongoing cardiovascular outcomes study, REDUCE-IT, the biopharma is burning a little over $10 million a month. If we factor in Vascepa's revenue and the company's current cash position of about $140 million, we are looking at cash runway that should extend comfortably into the second quarter of 2016.

    That should give the courts enough time to render at least a preliminary decision on whether to allow Amarin to inform physicians of Vasepa's potential benefits for patients with lower levels of triglycerides.

    Amarin stands a good shot at winning this legal battle against the FDA as well. After all, the company is simply requesting that it be allowed to speak to healthcare providers about the drug's other clinical trial data that "may" provide scientific support for a broader use in the real world. Given that Vascepa did show a statistically significant 21.5% reduction in fasting triglyceride levels compared to a placebo in the ANCHOR trial, there is some strong factual evidence to support Amarin's legal position.

    What the company definitely cannot say at this point, however, is that Vascepa lowers the risk of cardiovascular events. That issue won't be resolved until the REDUCE-IT trial concludes in either 2017 or 2018.

    So as long Amarin doesn't stray into these deep waters on the cardiovascular front, which would clearly constitute "misbranding," pharma reps should be able to tell doctors that a large clinical trial supported the hypothesis that Vascepa is effective at reducing triglyceride levels, without increasing LDL-C levels, in patients on background statin therapy.

    That's a statement of fact. And it's why this beaten-down biopharma stock could be setting up

  • Reply to

    Good summation

    by bentbasin Mar 13, 2015 4:54 AM
    centurycom centurycom Jun 1, 2015 9:00 AM Flag

    They were short at $1.93 and have no idea what to do to rectify their situation other than squeal sell while they get rectalfied..

  • Reply to

    ARTICLE: AMRN MASSIVE CALLS

    by beenlonging Mar 14, 2015 11:12 AM
    centurycom centurycom Jun 1, 2015 8:34 AM Flag

    You should go then.

  • centurycom centurycom Jun 1, 2015 7:01 AM Flag

    Shorts are mad as bees that just got their nest spayed and I don't blame them. After all, the gig is up.

  • centurycom centurycom May 31, 2015 11:58 AM Flag

    "What is VASCEPA?
    VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.
    It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis).
    It is not known if VASCEPA prevents you from having a heart attack or stroke.
    It is not known if VASCEPA is safe and effective in children.
    Who should not take VASCEPA?
    Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in VASCEPA.
    What are the possible side effects of VASCEPA?
    It is not known if people who are allergic to fish or shellfish are also allergic to VASCEPA."

    So you didn't know that triglycerides were associated with cholesterol? Fats in the blood stream also known as cholesterol.

  • centurycom centurycom May 30, 2015 8:32 PM Flag

    It all has to do with expansion of the label. The label is restricted to a smaller group for high trigs and prevents prescribing to a much larger group of patients. As far as growth is concerned a 73% growth yoy is good but until the label is expanded for all patients with high cholesterol it will not ever reach blockbuster status. There really is no reason for a proven safe drug such as Vascepa to be restricted in the manner in which it has been considering the known benefits of EPA and the safety profile. Something very fishy going on. The games the FDA plays, and thus the added cost to companies participating in the approval process eventually extends the cost to insurances companies and increases the cost of insurance to patients. They have made Amarin jump through hoops by canceling their SPA agreement on a whim which goes against the intent of Congress, but they seem to believe that they can change rules and regulations anytime that they wish for whatever reason.

  • centurycom by centurycom May 29, 2015 9:16 AM Flag

    POSITIVE TREND OF THREE HEALTHCARE SECTOR STOCKS: AMARIN (NASDAQ:AMRN), XOMA (NASDAQ:XOMA), ANTHERA (NASDAQ:ANTH)

    May 29, 2015 By Marry Johnson 0
    Three Healthcare stocks rose broadly on Wall Street so far on Thursday, with the sector seeing generally rise of +0.07%.

    The leading gainers among Healthcare stocks include the following:

    AMRN, XOMA, ANTH

    Amarin Corporation plc (NASDAQ:AMRN) has the market capitalization of $343.68 million and its EPS ratio for the past year was -0.37. The company ended business at $2.32.

    Amarin Corporation (NASDAQ:AMRN) announced that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin’s motion for summary judgment in the company’s lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa®(icosapent ethyl) capsules.

    Amarin Corporation plc is a biopharmaceutical company with expertise in lipid science focused on the commercialization and development of therapeutics to improve cardiovascular health.

ARNA
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