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Danburydude

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  • Update: Amarin Earnings Show It Blew Its Chance At 2014 Profitability [View article]
    You might want to call the folks at Stonepipe. They plunked down nine large on this going up. Looks like you have, oh, let me look, a big fat zero invested in your opinion. Have a nice day, say hello to your short buddies , and thanks for participating.
    Nov 24, 2014. 01:25 AM | 6 Likes Like |Link to Comment
  • Amarin's Value With Or Without REDUCE-IT And A Final Word On Management [View article]
    No reason to dilute when you sell some international rights for cash.
    Oct 23, 2014. 09:52 PM | Likes Like |Link to Comment
  • Update: Amarin Gets The Thumbs Down From The FDA....Again [View article]
    I guess the over ten percent increase in sales in just the last month means nothing ? Or did you mean to leave out that fact ?
    Sep 12, 2014. 10:40 AM | 2 Likes Like |Link to Comment
  • The FDA Oil Tanker Will Not Be U-Turned And Amarin Corporation Faces Collateral Damage [View article]
    Why did the FDA do what it did ? Because Dr. Nissen found someone who bent to his wishes of outcome studies before approvals . This is Dr. Nissen's back door way of attempting to run the FDA. A higher level may not be so receptive to Dr. Nissen's practices. I actually believe it is a 50 / 50 call. Will the FDA cover their rear end, or honor what they previously agreed to ? The answer is coming soon.
    Sep 11, 2014. 01:30 PM | Likes Like |Link to Comment
  • Update: Amarin Earnings - Company Making Progress [View article]
    May I address Sharkdude ? Could we possibly be seeing cracks in the FDA ?
    Let us go all the way back to Avandia. Dr. Nissen led the cry against the drug, along with Mary Parks. Mary Parks made her name on the back of Avandia. In a way, with Avandia under her belt, Mary Parks became the Erin Brochovich of the FDA. A public do gooder who has to be the watchdog for the poor, unsuspecting public.
    Now fast forward to AMRN. We have Dr. Nissen aligned with a competing drug for a rival company, AZN. We have Mary Parks, self appointed public do gooder. Dr. Nissen has Mary Park's ear. He has financial incentive to see AMRN side tracked . Dr. Nissen could have influenced Mary Parks enough to pull a hatchet job on AMRN, all in the supposed interest of public safety. After all, isn't the FDA supposed to be all about public safety ? So Dr. Nissen convinces Mary Parks the best route to go with AMRN is to wait until a heart study is over before going ahead full bore. Mary Parks agrees because she wants to be 1000 % sure about the benefits of Vascepa. After all, Dr. Nissen is a leader in the heart health field, and Mary Parks is the self appointed do gooder of the FDA. And who is going to question the Erin Brochovich of the FDA ? After all, she saved the public from Avandia.
    Now, lets go to the studies cited by the FDA to side track AMRN. Why, no other than Dr. Nissen was trumpeting those same studies. And who was the hit blogger citing and with what studies ? Why none other than Dr. Nissen and the exact same studies Dr. Nissen was trumpeting. Odd, the studies the FDA ended up using six months later in the ADCOM was cited in hit blogger articles citing Dr. Nissen. How about that coincidence ?
    Now I want to cite an exact quote from an article Dr. Nissen wrote on May 23, 2013 about an Avandia hearing. " The current Director of CDER, Janet Woodcock , has directed this division for nearly 20 years, increasingly insulated from the Agency's true constituency , the American public. " It sounds like Dr. Nissen has appointed himself to be the people's advocate, in place of a woman who actually heads part of a government agency. Why, Dr. Nissen knows better what is best for everyone, instead of Janet Woodcock !! That sounds like anything short of faint praise for the person heading CDER. By the way, that article was published in the same month the hatchet job for AMRN was being finalized.
    So I theorize the pulling of the SPA was orchestrated by the division Mary Parks is involved in. I theorize Dr. Nissen was pulling puppet strings. After all, Dr. Nissen has acknowledged that he knows what actions are proper as compared to the insulated Janet Woodcock. I say there are people inside the FDA who will give Mary Parks a wide latitude because she is the Erin Brochovich of the FDA. I also say that CDER slam dunking what has happened so far is not a sure thing. Would Janet Woodcock slam dunk a plan hatched by Dr. Nissen if he has a negative view of her ? To slam her in print is not exactly publicly praising the woman. It sounds as if there is a division with in the FDA.
    Janet Woodcock may want to make this right. It could quite possibly be a lower division pulled a stunt that was not thought through. Perhaps that division did not think though all the ramifications through out the industry . That division may not have contemplated the political fall out. That may be why those people are still not employed at higher levels within the FDA. In doing so, all Woodcock has to do is go against an Erin Brochovich type, and a leading expert who has financial incentive for AMRN failure, and an axe to grind. It makes for interesting theater, with people's health hanging in the balance.
    Aug 10, 2014. 02:58 PM | 1 Like Like |Link to Comment
  • Amarin's (AMRN) CEO John Thero Presents at Jefferies 2014 Global Healthcare Conference (Transcript) [View article]
    Wonder if the FDA is gonna have some empty chairs soon? Wouldn't be good, they provide the hit blogger with his inside information that he trades on .
    Jun 5, 2014. 01:17 PM | Likes Like |Link to Comment
  • Analysis Of Oral Argument In Vringo Vs. Google Patent Infringement Appeal [View article]
    It looks more like shorts manipulating. Shorts drove it down to cover, and are now going long via calls. Typical crap in a manipulated market. Just ride it out. If the shorts know the writing is on the wall, you should too.
    May 7, 2014. 03:27 PM | 6 Likes Like |Link to Comment
  • Amarin: Today's Market Is Underestimating The Probable Success Of REDUCE-IT [View article]
    I don't think dead money for two or three years. This KOWA thing intrigues me to no end. I actually really like the move. If BP isn't careful, they may have gotten something they did not foresee. A potential up and coming " partnership " that slipped right through BP's fingers due to greed. Is it possible AMRN blew it for awhile due to greed, and then have it turn around and have BP blow it due to greed ?
    Apr 6, 2014. 01:41 AM | 1 Like Like |Link to Comment
  • Amarin Is Likely Now A Vortex Where Your Money Will Go To Die [View article]
    Curious timing on a basic rehash article. Trying to get people to sell cheap shares before the conference call . Why?
    Feb 26, 2014. 06:50 PM | Likes Like |Link to Comment
  • Amarin: 3 Things Shareholders Should Demand In 2014 [View article]
    Thank you for the comment. You are correct that the AD COM had to be held. Perhaps I should have said the reason the FDA held firm to their question is because they wanted to know what language to put on the ANCHOR label. I still maintain there will be an expanded label , but only saying reducing in the 200 to 500 range.
    But if AMRN put language into a final ANCHOR application about reducing CVEs, that is huge. The FDA just cannot let such a claim slide by.
    Imagine a drug going onto the market where the company can make a claim about an FDA approved drug that will reduce your chance of a heart attack ? That drug would sell hand over fist. That is why the FDA has to be very, very , very careful about any drug making that claim. Not to mention the liability issues if such claims turn out to be false in the future.
    Jan 9, 2014. 01:00 PM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    That is what everyone is forgetting. This company was built for one thing only, a buy out. AMRN never intended to go all the way through with REDUCE-IT. The acquiring company was going to finish that study.
    It darn near happened in October , 2012 with AZN. It seems Joe Z. deemed a price in the low to mid twenties too low.
    I will play the guessing game, because some stars might be aligning.
    AZN got Epanova when they struck out with AMRN. The PDUFA date is May 5th. Epanova fails to get approval. By then, the application problems and a delay is solved for AMRN. Look who now has an expanded label drug . Why , it is AMRN.
    Look who suddenly wants that drug. The very same suitor from October , 2012. AZN .
    If the stars align right, I say AZN acquires AMRN this summer . Only this time, AZN will get to pick the price.
    Jan 4, 2014. 03:10 PM | 2 Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    Why would AMRN try to squeeze REDUCE-IT language into the ANCHOR application ? Greed. REDUCE-It language now equals a higher buy out price now. Remember, AMRN was built for a buy out. The better language you get into ANCHOR , the more money you get in a buy out , now . Simple economic answer.
    Jan 3, 2014. 04:43 PM | Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    Yazz, you are missing the point. The FDA tried to help AMRN. The only reason for the AD COM was to try and include REDUCE-IT language in an approved ANCHOR indication.
    Why ?
    Because Joe Z. got so cocky and so arrogant he thought he could sneak through some language using the SPA as cover. He got caught with his hand in the cookie jar.
    If the FDA really wanted to shoot down this drug, you would have seen a CRL on December 20th.
    The FDA has actually been behaving logically EXCEPT for the pitiful science changing excuse That is what has everyone in a tizzy. It is a bad excuse, and what the FDA should have done is come out and said, hey, reapply for the correct indication.
    Instead of bashing the FDA, they should be given credit for attempting to give AMRN REDUCE -It early. That is why the AD COM was held. To see if REDUCE_ IT can go on label now. If the AD COM had come to a thumbs up, people would be praising the FDA for being forward thinking.
    The FDA is like any current government agency right now. Bloated, semi corrupt, and burdened by too many unnecessary rules and regulations.
    Why is it beyond the realm of possibility that AMRN violated their part of the SPA, and the FDA is trying to legally stay within set rules and regulations to get a proper ANCHOR application approved?
    Looking at both sides, is it just impossible for AMRN to have screwed this up ? It is not possible that AMRN management is not the infallible angels ? Is it impossible to think the FDA maybe didn't change all accepted thinking about cholesterol drugs just to screw one little pharmacy company ?
    Or could it just be one party getting greedy and breaking an agreement, and the FDA trying to find a regulatory and legal reason to get a proper application accepted ?
    AMRN could clear this up, but their silence about this speaks volumes. I truly believe AMRN shot themselves in the foot, and the FDA is trying to find a way to get the proper application filed, and accepted.
    As a side note, don't fall into the trap the hit blogger set. He beat the drum for the change of science lame excuse. In actuality, it may have been a paper work over reach. But by beating the drum early, and often, he has people not looking for other possible explanations. Please people, do not dismiss another possible explanation just because the FDA is semi-slimey. Could it just be possible the FDA is trying to save AMRN from themselves. Actually ponder that question.
    Jan 3, 2014. 04:38 PM | Likes Like |Link to Comment
  • Amarin: 3 Things Shareholders Should Demand In 2014 [View article]
    Almost two years long. Bought at seven, sold most after the GIA strategy . Knew it would be a year. Bought back again this fall. Been buying more at this level.
    Jan 1, 2014. 09:39 PM | Likes Like |Link to Comment
  • Amarin: 3 Things Shareholders Should Demand In 2014 [View article]
    Unless the SPA is broken by the FDA, the FDA had to approve the ANCHOR final submission made by AMRN on December 20th. I believe the FDA is trying to get ANCHOR approved , but only per the original agreement. I believe AMRN forced the FDA to break the SPA. Both sides need to go back to the original SPA, and AMRN needs to resubmit a correct ANCHOR application.
    Jan 1, 2014. 05:29 PM | 1 Like Like |Link to Comment
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