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Hey Bill: It's been a long time pal. How are you ?
The board is unrecognizable, it's been so long.
I'm still pulling for you guys, and just wanted
you to know that I also heard AZN mentioned re AMARIN.
Take care and I hope this puppy comes through for all
the longs. IMO AZN is not known for any financial funny
stuff, but they desperately need drugs.
BB: I would interpret it differently. I believe that
the trial will go through to completed in 2018, and
not be stopped at interim, if only because FDA has
never done one positive thing for AMRN. They'll
spin it ! Same song, different verse.
JL: I AGREE WITH WHAT YOU SAY. We should all short AMGN , REGN,
SNY, AND PFE. AMGN JUST CHANGED THEIR REPORTING OUTCOMES DATA TO 2017. IT WAS DUE IN Q3-Q4. I BELIEVE THE DATA WAS TRENDING TO, AND NOT ACHIEVING STATISTACAL SIGNIFICENCE. LOVE TO HEAR YOUR SCIENTIFIC BASED ASSUMPTIONS AGAINST LDL-C. I WOULD ASSUME THAT THERE IS A LACK OF SIGNIFICANT ANTI INFLAMMATORY ACTION ON THE CORONARY INFLAMMATORY BIO MARKERS, LIKE CRP ETC.
AJAX
sts: HDL as a Lipid metric has lost it's merit and
credibility. You are correct about artificially raising
HDL and not cutting CVE's. Even naturally elevated HDL
doesn't convey the predictability of statistically
lower CVE's that it was thought to in the mid 80's up
to about 2005.
bidmark: Great question. JZ wasn't invited to the Anchor
ADCOM either. For his " pumping and dumping" prior to the Marine
approval (July 2012). He insisted that he had more offers than Employees, and the stock jumped up to $19+ and he then sold millions of dollars worth of stock. The FDA called that pumping and dumping. That is specifically the reason why he poisoned the
well as far as relations between AMRN and FDA. He then compounded his mistake by selling millions of dollars of stock on the first day's trading after the Marine Approval od Vascepa. This was and still is unprecedented in Biotechnology. To my knowledge he is still on the BOD, though I haven't checked in a while.
bidmark: Great question. JZ wasn't invited to the Anchor
ADCOM either. For his " pumping and dumping" prior to the Marine
approval (July 2012). He insisted that he had more offers than Employees, and the stock jumped up to $19+ and he then sold millions of dollars worth of stock. The FDA called that pumping and dumping. That is specifically the reason why he poisoned the
well as far as relations with FDA He then compounded his mistake by selling millions of dollars of stock on the first day's trading after the Marine Approval od Vascepa. This was and still is unprecedented in Biotechnology. To my knowledge he is still on the BOD, though I
haven't checked in a while.
Zum: It's been along time, hope you're well. I was not at
all surprised by the financial statement showing that
Management padded their pockets to the tune of $20M.
When I started talking about how the CEO et al were
totally incompetent and only staying on to collect a
paycheck, some of the Board were irate. It's to late
in the game to do anything now. That said, the new
Cures legislation includes allowing Co's to market
their drugs off label with the same requisites that
apply to AMRN. Management spent a fortune and won nothing,
other than about a 6 month head start. You all still
have not obtained the NCE. What has management accomplished ?
Absolutely nothing except to keep their paychecks coming. Most
decent Biotechs when cash strapped as AMRN is cut their
salaries, and don't reward themselves with stock options
and bonuses. You all are so close to the situation that
you can't see the forest for the trees. When a CFO leaves
as AMRN's just did , it's usually because he sees the ominous
signs of failure. One important fact that I kept telling you
about was the major issue of not being fully enrolled. That
affects the Hazard Ratio as well as Power of R-IT. It has
most likely turned R-IT into a binary event. I am still rooting
for Vascepa, but have the same strong doubts about the company's
survival. I hate to see all the longs lose at the end of the day,
after all you've been through.
ladavis: You are completely correct on your assessment of
this disaster that we all got involved with about 4-5 years
ago. My only caveat is the Co doesn't have enough credit
to do a financing that would fund exploring another indication.
At the end of the day it's a binary event on R-IT.
JL: Completely agree. I am not looking for a management change.
It's 2 years too late. It just offends me that they are in this
just to keep their paychecks. My grandmother told me the very
same thing. Must be generational.
Best regards.
ladavis: Inept management whose only accomplishment
is to add to their paycheck by awarding themselves
bonuses for doing nothing. Oh I forgot the great FDA
settlement.
JL: I am not at all surprised by this mockery of justice.
My conclusion is consistent with my major issues with the
Company. Terrible management, has plagued AMRN since I
first became involved with the stock. I have no intention
of reiterating my myriad gripes. I'm sure you all are aware
of every wrong headed decision that this mgmt team is
guilty of.
mrmain: The reason is because the PPS of AMRN is so
inexpensive, that it is tantamount to buying a call
option without time erosion. Upside is identical if
you buy an at the money call.
bblack: A 35 PE is excessively high for either a growth stock
or any Biotech on the Board. This seems to this observer that
you are all trying to guess how many Angels dance on the head
of pin !!! I gave up two years ago as a mastubatory exercise
in futility. There are just too many variables that no one
can understand until it's in the rear view mirror.
mog: You may be bright and write intelligently, but
you are terribly naive to believe that with two Federal
Court wins, AMRN won't win at the end of the day. AMRN
management, with the able assistance of their first rate
Legal team, has done everything right thus far. As you
may have gleaned, I have never been a fan of Managent,
but I give the them Kudos on these important negotiations.
chas: The oddity of Jellis is that the trial was never accepted
by FDA, It didn't comply with PH III protocol, enrollment criteria, etc, or the results using sub optimal dosing of EPA with a disproportional number of women. A point that disturbs me is that
registrational trials based on Sub Set analysis of prior trials have failed to hit endpoints or be approved the majority of the time. This goes back 20 years. I truly hope this isn't one of those results.
BB: Excellent response !
All: Does anyone have a take on why AMRN is going
along with these delays. Surely FDA doesn't want
the Temporary Injunction to become permanent . I'd
love some enlightenment, particularly on how AMRN
benefits from delays.
AK:I tend to agree with you as well. What stumps
me is that all assumptions on the Board are predicated
on Jellis, a trial with a very different dempgraphic
mostly enrolled with women, low Tigs, never accepted
by FDA as a valid clinical trial, nor to my knowledge
ever reviewed by a PEER Journal. To make it the comparator
trial for R-IT seems to me to be a leap of faith. Would
one of our knowledgeable posters please explain the rational?
Do recall that subset analysis is not considered acceptable
to FDA.
invest: I agree unfortunately The S&P could easily
test major support at 1780, and if that doesn't hold
which I personally think it will, the next major support
comes in at 1670.
BB I disagree. The drug is priced at $53.6K and will
be discounted to $44K-$46K . This is roughly in line
with GILD's discounted pricing. It is really not
comparable to Sovaldi/Harvoni, as it only treats 2 of
6 genetic sub types of Hep C, GILD's treats all 6. All
of MRK's patients have to be tested for the genetic sub
type.
AK What I'm having trouble with you, ZUM and everyone else who
treats Jellis like it was the gold standard. If you recall back
in 2011, we all only wished that it was a legitimate Clinical Trial.
Well, FDA never accepted it as it did not meet most of the FDA
approved standards and metrics, enrollment criteria etc, etc. It was posted here on this site that Jellis wasn't the accepted standard. Soooo , why are we going back to what I perceived was not considered a legitimate trial. I first noted this on one of the occasions I visit this board several weeks ago, but thought maybe something changed. Well it didn't, and I would appreciate
your take, for the sake of clarity and fact.
Continued: Sen Charles Grassley R Iowa are
heading the Investigation
BB: Senator R Wyden D Or and
BB: You're a bit over the top. FDA will never be
obliterated or even get their wrists slapped. I
believe you're personalizing the AMRN situation,
but exacting revenge and seeking justice is a bit
much. Congress is only trying to have them redraw
guidelines dealing with more extensive off label
drug use and increase generics to be more cost effective
for ACA. Until the new pricing models are worked out I'm
suspect of any near term resolution in the negotiations
between AMRN and FDA. The negotiations include BIO, PHRMA, Congress, FDA, PBM's and Insurers. Pal, it ain't about AMRN
Reimbursement going forward will be based on patient outcome
data, individual responses, and a sliding scale based on
outcome data. You're starting to sound manic. Calm down Pal
or you're looking at significant medical problems.
BB: I don't think so. The negotiations are basically
involving FDA only in incorporating Agency in getting
involved in "Pricing Models" probably limited to tying
pricing of new drugs to patient outcomes and results.
I've been told that they are exploring 3 different
models. IMO it will wind up not lowering pricing power,
but reimbursement will be predicated on patient results.
One huge issue discussed is allowing more off label use
for small subsets of patients that show efficacy and safety.
Again off label use will incorporate reimbursement based on
patient results. For example full fee would be reimbursed
on a sliding scale based on outcomes.
Drug Pricing:
FLASH NOTE - DRUG PRICING REGULATION: HOUSE HEARING BUT NO ACTION IN 2016 OR BEYOND
Next Tuesday, January 26, at 2pm US eastern time, the US House Oversight Committee will hold a hearing on drug pricing entitled "Developments in the Prescription Drug Market." This hearing will not lead to any legislative action on drug pricing regulation. We stick with our call that no action on drug pricing regulation will happen in 2016, and almost certainly not in 2017. Nothing happens on drug pricing in 2016 except political posturing in an election year designed to make drug pricing regulation a political wedge issue.
No congressional action on drug pricing regulation in 2016. This hearing creates minor headline risk because pharmaceutical sector investors are concerned about any interest in drug pricing regulation from Washington, even if it is a hearing in a House committee that cannot legislate on the issue. This is not the first hearing on drug pricing in this Congress: the US Senate Select Committee on Aging - another committee without the ability to legislate - held a hearing December 9, 2015, that heard testimony from several drug manufacturers.
Congressional Republicans, the majority in both houses of Congress, oppose regulating drug pricing and will stop all attempts by congressional Democrats to do so. Republicans have consistently opposed price regulation in health care since the Affordable Care Act became law in 2010 without a single Republican vote in either house. Republicans want ACA reforms that remove government intervention in health care markets and cite price regulation as a major reason for ACA's failures. The general Republican anti-ACA policy position has been popular with voters, who seem in polls to consistently oppose ACA and to desire its repeal or change. ACA opposition was instrumental in creating the current Republican congressional majorities, which are committed to "repealing and replacing" ACA with something else.
Congressional Democrats understand their inability to effect drug pricing regulation since they are in the minority but are using public dismay about rising drug prices to call for regulation. House Democrats last fall created a "task force" as one means of calling attention to drug pricing issues. Congressional Democrats have not always been so interested in drug pricing regulation: when congressional Democrats held the huge majorities that created ACA in 2010 they acceded to Obama Administration deals with the industry that kept ACA from including drug pricing regulation in exchange for industry ACA support. Members and Senators in both parties understand that voters are concerned about rising drug prices and that many polls suggest the public is interested in government action. We think Members and Senators are open to discussing and considering potential solutions to rising drug prices, including ways that the government could negotiate more effectively with drug companies. But regulators are not yet ready to suggest effective solutions (see our discussion below), and Congress will not step in during an election year when bipartisanship on the issue is unlikely
always: This is all public record. Check it out
yourself. I was observing it in real time. This
is all in the public domain. Try doing some of
your own diligence and open your eyes.
Everyone: This is part of what I've been posting
for over two 2 years and reflects the sad state
past and present of management. Read the link that
Mog posted. Name one thing that management has done
for shareholders since inception ? I thought so ZIP !!!
JZ is still on the Board and IMHO singlehandedly turned
the FDA against AMRN and cost this Board tens of $M .
Continued: JZ was solely responsible for poisoning the well.
His actions brought about our ,winding up in FDA hell. The truth hurts, and though I don't know ladavis, he's spot on for the position AMRN now finds themselves in. FDA is playing the old North Carolina "Four Corner" game and is in a deliberate Stall.
FDA still plays without a "Shot Clock"
JL: Nice to be remembered, though I am convinced that your
Bud
Kiwi: You are stating the obvious. Actually the BB's
got involved long before HRC opened up her political
sewer. R=IT has nothing to do with my point which is
an attempt to calm the Board.
marzan: The PPS of AMRN has nothing to do with either fundamentals
or Management ( Never said that before ) but rather the Bear Market
we have either entered or may be entering. In Biotech the pricing headwinds are formidable. Small Cap names without major revenues , earnings and in AMRN's case pending R-IT results (which are no slam dunk) is the major reason for the XS selling.
JL: Excellent piece with a Runyonesque flavor. " I like the action"
Can't disagree with your logic against the "Blame Game" as it
is a 'losers" mentality. I don't believe that's the case here.
In the Market, Biotech in particular, I have always believed that
fundamentals trump most all other variables. That said, and I'm sure
you would agree, most successful bets have had a great Jockey, and in equities that means the CEO. My bets that have turned out well over time have always been with a great Jockey in the saddle. In my mind JZ is now banned at most Race Tracks. He was the wrong Jockey at the wrong time to bet on. In defense, Who Knew ? Warren Buffet, Steve Jobs, John Martin (GILD), Gordon Binder (AMGN) . CELG,(Robert Hugin) REGN,(Len Sleifer) DNA,(Art Levinson), JUNO (Hans Bishop) and on and on.
bio : Who do you think pissed off FDA in the first place,
and why was he not allowed to attend ADCOM ? Your old pal
JZ !
sts66: My apologies ! I was under the impression it was your
post. Sorry, I couldn't believe it was you of all people. Btw,
I didn't acknowledge the major accomplishment of management.
They are still drawing a steady paycheck. Damn the shareholders
full speed ahead.
sts66: My apologies !
ladavis: They also awarded themselves bonuses and options
for the "successful financing's" they presided over. What
a bunch of losers. The
dm: Than simply ignore it !
Bio: My information is widely known, but my sources
are confidential. Even you can understand that. It
is my choice. I owe this board nothing, other than
the info I choose to disclose. I would prefer not
hearing from you again. In 4+ years you have never
told us anything that many of us already knew.
dm: Just maybe confidential information can not
be publicly disclosed. A thought no one on this
site appreciates. lad has hit most of the pertinent
facts and is accurate. Doesn't mean he is not an
AMRN long. Just that not everyone has access to
the same level of information. A Wall Street fact
of life.