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sts66: A salient point, they had 6800 patients
enrolled more than 6 months ago.
MRMAINSTREET: CHECK OUT MY CREDENTIALS.
YOUR PRIVATE POST IS A PERFECT EXAMPLE
OF YOUR MISGUIDED CONCEPTS ABOUT WALL STREET.
THINK of Wall STREET AS A HEART WITH ARTERIES
AND VEINS. IF THE TRUTH BE KNOWN I PLACE MORE
BLAME ON DOEDD/FRANK, PARTICULARLY BARNEY FRANK.
HE WAS SOLEY RESPONSIBLE FOR THE CONCEPT OF EVERY
AMERICAN OWNING A HOME. A COMMENDABLE CONCEPT.
BUT MAKING NO DOC HOME LOANS THE NORM, WITH 125%
MORTGAGES NO LESS. WALL STREET WAS COMPLICIT FOR
SURE, BUT FAR FROM THE ONLY CAUSE. AS A HEART, THE
FUNCTION IS TO PUMP BLOOD INTO THE BODY. WALL STREET
DOES THAT WITH PUMPING MONEY INT THE ECONOMY. WIOTHOUT
WALL STREET, WE WOULD RAPIDLY BECOME A THIRD RATE NATION,
THOUGH CURRENTLY WE ARE ONLY SECOND RATE.
YOU REDEFINE JERK
MRMAINSTREET: My last word on this matter.
You obviously have no Wall Street experience,
though I don't accept ignorance as an excuse.
Wake up. Kowa was two years too little too late.
Thero doesn't have the credentials to be a CEO,
and has constantly proven it. Check for yourself.
I will not waste any more of my time with this
pointless dribble, from arguably a poorly informed
person.
mrmainstreet: Many PM's on the street have
access to the same information. AF was not the
only one to have FDA sources of information.
Why have most of the Hedge Funds, Insiders,
sold hundreds of millions of AMRN shares. This
is the most incompetent Mgmt team in the sector
Name JUST ONE THING they have done right in the
last 4 years ? They have cost this Board 10's
and 10's of million of $'s. It appears you are
locked in to an incorrect belief system. There
are myriad issued that Mgmt wont admit to without
opening the flood gates to litigation. Question,
JZ poisoned the FDA well. One other item, despite
being fired why is JZ still on The BOD. You can
only rebut, but you are blindsided by a reality
that you refuse to even consider. Wake up pal,
and tell your one supporter that if his knowledgable
head was any further up his ass, his Surgical Skills
would allow him to do his own tonsillectomy.
mrmainstreet: Many PM's on the street have
access to the same information. AF was not the
only one to have FDA sources of information.
Why have most of the Hedge Funds, Insiders,
sold hundreds of millions of AMRN shares. This
is the most incompetent Mgmt
MRMAINSTREET:" I guess you are correct. You
are neither bright nor articulate. Repeat
after me, "There are some things I must
understand, that there are some things I
can't understand" Maybe repetition will be
helpful to you.
MRMAINSTREET: You Sir are the Poster Boy for
the age old adage pointing to the disconnect
between Main Street and Wall Street. Not being
in the business you lack the ability to
understand the professionalism that people
whose business is Wall Street covet and protect
their sources, or lose the ability to source
different information that is essential for their
competitive survival. I am chagrined that a bright,
articulate guy like you can't understand that.
Shame on you!
HDGABOR: With all due respect, I can't really
disagree with you on the science. Please read
my most recent post, I believe it will give you
some clarity on my thinking. Hey, just one man's
experience opinion.
Thanks a lot , it's a freaking shame.
LOTSALUCK: You're right and wrong. At least
my take is that if it's not in the treatment
guidelines, AHA/ACA hospital protocols. they're
is a big reimbursement issue, as CMS reimburses
only for what are listed in treatment guidelines.
I hope I'm wrong, but I believe FDA will
do whatever they have to do to cover their
butt. That unfortunately is standing by the
new guidelines. If they go along with reinstatement
of the SPA, they shoot themselves in the foot
by basically shining on Congress. After all,
their funding is I/2 PDUFA and the rest is
funding from Congress. They're already on the
Hot Seat. I just have never seen FDA beat their
chests and yell "Mea Culpa" Believe me I wish
it goes AMRN's way. I have spoken on Vascepa
several times. I'm a believer! Bottom line
even though it's Biotech, remember that it
is also Political. They will save their Arsyss .
ggwpq: I appreciate your comments. From what I heard,
and I honestly don't know it 1st hand, I'm led to believe
that FDA received a final draft copy of the new guidelines
a couple of weeks prior to ADCOM. The guidelines were made
public following the panel meeting. They would have been able
to give AMRN a heads up without usurping AHA/ACA predetermined
release date. As to why not compromise, beats the hell out of me. All FDA wanted was to revise the SPA,and approve Trig treatment of 199-499, but make final approval dependent on RI results. It always struck me as fair and a win/win for both sides. Bottom line FDA always has to save face. They honestly believe their on going credibility is essential to carry out some of their very challenging demands on a day to day basis.
sts55: I hear you but I have 3 caveats.
1-Whoever said FDA is fair and forth
coming. Al Mann had to pony up over $1.3B
of his own money to finally get an approval.
It makes monetizing the 5 yr delayed approval
almost impossible.
2-FDA can and will say whatever is necessary
to defend themselves. Don't forget PDUFA only
funds about half of FDA's budget.
3-They will be more concerned about a defense
that will pacify Congress. IMO, standing behind
New Science does that. No one in Congress will
go against that, or has the ability to over throw
the AHA, ACA Guidelines.
Believe me I've been behind V for 4 miserable
years, and I only hope I'm flat out wrong.
MRM: Yes it can be proved, however, not publically.
You are so blind that you can't see the forest for
the trees. The only thing this Mgmt team has accomplished
is to put the stock in a death spiral, GIA, and be clueless
about everything else. To my knowledge JZ
ladvis23: I have always felt that a change
in Mgmt would be a strong positive. This
team had been assembled to sell the Co.
following the Marine label. That didn't
happen. They don't have the required skill
set to be fluent in FDA speak, commercialize
and monetize an asset. Further more they
showed no ability to gauge FDA actions, and
missed an opportunity to compromise with
FDA when the SPA was put back on the table.
That error was followed by the FDA again
rescinding the SPA on the 1st business day
following their Friday meeting on MLK weekend.
I can't speculate on PPS. It would be a pure
guess.
Blind Sided: I occasionally visit this board to take the
pulse of our loyal and determined longs. It occurred to
me that of all the valuable information on this Board,
the missing link is "What is FDA thinking ? What is their
legal team's thinking as to the best way to DEFEND the
disgraceful handling of the SPA, & Anchor Adcom meeting ?
I have been a strong advocate of Vascepa for the last 4 years,
and still believe reinstating the SPA is the right thing
to do. That being said, the FDA doesn't give ice away in
the winter time. Historically the FDA is vindictive, petty
and basically always covering their own ass , often at the
expense of the Sponsor. Think MNKD ! Having served on two
Advisory Panels (Oncology) I do have a sense of Agencies
thinking. Anything short of defending their decision making
and saving face, has never occurred. There is always a first
time, but I wouldn't bet on it. Preserving a good relationship with Congress trumps all else, and having sound rational is
an imperative. My conclusion, JMO, is that they will state that
their rescinding the SPA was based on new science. They will
hide behind the new AHA, ACC guidelines. Trigs were never mentioned in the guidelines. The only non statin lipid lowering
agents referred to in the guidelines were to lower LDL C. There
is a large body of evidence that completely negates their stated
opinion that lowering Trigs does not lower CVE's. I doubt they
will ever own up to the importance of lowering Trigs, lowering
inflammatory markers etc. I believe they will hide behind the
new ACC, AHA guidelines and in a positive tone state they are
anxiously awaiting RI results. Having the two largest Cardiology
Groups as their cover will probably allow them to easily get away
with this fiasco. They may acknowledge that they found out about
the new guideline so close to the Adcom meeting that they didn't
have time to notify AMRN. They may say they were so taken by the surprise in the changes that they may not have handled things in an orderly, and well thought out way. They may apologize, but stick with their being totally surprised by the new guidelines. JMO.
Chica: It was documented in the Press as on
purchase at @3:10 pm Thursday. WTF does
Monster know about option trading, other
than generic info which doesn't apply on
this very unusual trade.
Investor: Another typo, That should
be SEC, not FDA
Invest: JL's comment was nonsense. Bloomberg
News thought it was so unusual that they
interviewed me twice (2nd was just a follow up)
The Title of the Bloomberg piece was "Unusual
Options Trading" Sorry to say I have no follow
up other than these cases can take a long time
for FDA to unravel.
jpsebastiL Typo !
sts66: As to your question the other day re: the
massive Put Trade, I thought I would fill in some
of the blanks. The trade was the purchase of 100,000
5.5 out of the money Put Contracts on a Thursday one day
prior to Options Expiration Friday. AMRN was trading a
little over $7/sh at the close on Thursday. The trade
occurred at about 3:10 pm , 50' prior to the close. On
Friday the FDA news was released and the stock tanked.
100,000 Put Contracts is the equivalent of being short
1M shares.The purchaser exercised the Puts into stock,
covered his short position into the massive selling.
He walked off with $310,000. I personally reported this
to the SEC just prior to the close on Friday. I was also interviewed by Bloomberg about this about a week later.
I have no idea as to what the SEC did, but was told about
3 months ago that it was still under investigation. I
hope this gives you all the information you wanted.
zman: The guide lines were publically released
about a month later. FDA was aware of them, and
unfortunately handled it badly. How could they
use guidelines that hadn't been publically released ?
STS66: As you know I have great respect for you,
past, present and future. I was only stating fact
and responding to an attack on colleagues who
got hurt. Yes we are all responsible for our own
investment decisions. That said, the one person
who knows more lipidology than any other poster
on this site. repetitively stated accurate information
that won't be accepted by Cardiologists for quite
a while. Yes I believe in the inflammatory etiology
of Coronary Artery disease and stroke too ! The
problem is we got out too far in front of the wave.
Hey BB, It's been a while since I've been here
and good to see you up and about. The reason
IMHO that Anchor went south, is because the FDA
was informed of the new ACC/AHA guidelines, and
followed their lead. They do not include Triglycerides
as a Non Statin Lipid Lowering Agent. The only one
they site, is LDL. They are also requiring Outcome
Trials for LDL as well. The FDA will hide behind
the New Lipid guidelines to explain the SPA rescision.
Do I agree, "NO" !!! But that is unfortunately the
reality. Hope all is well .
JPSWEBASTI: If you review my posts, I stated before
ADCOM that I don't play binary events. Not my cup of
tea. I sold prior to the panel meeting, at an average
$7.18/sh and posted it before the event. You're new,
as I have never read you before. If you don't know
what you're talking about, it would be prudent to
say noting.
Chica: Your comments have been t6he only constant
on this Board. You've never contributed anything of
value. My Kool Aid is that Mgmt is the worst in the
sector, and has precipitated the stocks death spiral
over the last 3+ years. Thero could have had a deal,
and blew it. Get a Life.
JL: They are not crybabies ! They were influenced
by drinking your Kool Aid. It poisoned the well for
the whole Board, and lost $10's M and $10's M for
your acolytes. You wanted and praise GIA. They
followed the Board guru ! You were against Reps,
another blunder. These guys bought into your
thesis, and now your ripping them as crybabies.
You should be ashamed of yourself. Own up to it !
Chabojilo: You are absolutely correct on all counts
with the exception of the change in Trigs from 150mg/dl
during the early enrollment of RI. Then the CMO of AMRN
requested a change to >200mg/dl. Sort of an afterthought
following the enrollment of the first 2,000 Pt's. The
irony of this fiasco is that is FDA originally used
150mg/dl for enrollment criteria and AMRN could have
easily requested 200mg but apparently didn't request
that until after the first 2000 Pt's. My guess, and
that's all it is, is that JZ had hot pants to start
enrolling so they could file for Anchor. Again a
guess on my part, but I bet that JZ' exit strategy was
for a BO following filing for Anchor. I'm pretty sure
he never thought he'd be there for the RI results, and
rather than negotiating with FDA for Trig levels over
200mg/dl, wanted to immediately start enrolling and
never uttered a word. In a sense he was half right,
he got fired. My only solace is the median Trig level
after that was probably North of 300mg/dl. Hopefully
that will skew RI to better data.
birzibho: Thero did say North of 200mg/dl, but he
wasn't referring to the initial 2000 patients that
were enrolled early. The change was then moved by
agreement of FDA to 200mg/dl
goamrn: Unfortunately the DSMB is an Independent Board,
and only they have that power, unless there are safety
concerns, and obviously FDA can take a look.
ggwpg: Let's agree to disagree, but bottom line
we've only enrolled about 800 patients since
October of 2013. That's 8 months, and very
modest. The event rate is based on the Power
of the trial and Hazard ratio. Being fully
enrolled is essential to hit the event number
sooner rather than later. The first 2,000 patients
were not representative of the higher risk patients
we desperately need. Ketchum,(CMO) was obsessed with
enrolling patients so that they would be "substantially
enrolled" so as to file Anchor. Most of the first 2,000
Pt's had Trigs at or slightly above 150mg/dl, and was
finally changed with FDA approval, to >200mg/dl. Most
folks on this site dispute this factoid, but one only
needs to call IR to confirm this.
Kiwi: Nice post with some interesting questions that
only need positive answers. A question for you. The
Japanese diet is quite different than US diet. They
ingest the lowest amount of dietary Omega 6, which
most folks agree is a major culprit in the US diet.
How do you respond to this ? Thero's talk at Jefferies
was IMO a disappointment. Only slightly more coherent
than his prior talks. Unfortunately only 6800 patients
enrolled in RI thus far. This is critical in getting to
60% event number in the near term. The last enrollment
metric was 6 months ago and was 6,600 patients. I think
this is a major concern, and though most Co.'s in PH III
Trials have a major slow down in enrollment in the later
stages, only 200 new patients is problematic for myriad
obvious reasons, notably completing the trial from a financial
point of view before this game is whistled over. One last
point which was disappointing, was that Thero mentioned
inflammation only in passing. Maybe your mentor should educate
him.
BioBill:GSK's corruption troubles grow; UK Serious Fraud Office starts investigation SHANGHAI – Glaxosmithkline plc has confirmed the company is under investigation by the UK Serious Fraud Office (SFO). The case is presumed to be related to the almost year-long corruption investigation into GSK China activities that came to a close last week.
LABNER: Excellent post: You have a good handle on this
latest "Rape" of the shareholders. Unless and until this
Mgmt Team and BOD are removed ( which I have been lobbying
for the last 3years )I can't possibly imagine a good outcome
for AMRN. This board has been all too trusting and believing
of all of the misconduct, lack of transparency and deceptive
shenanigans including the botched handling of the SPA fiasco.
Take a hard look , this is a disgraced Management Team.
NO MO: I personally appreciate your post.
I have no axe to grind.
drrc> That's your choice. Sorry, but I am
unable to talk. Why am I here. i
Ziploc: A- FDA took it off the table.
B- Who would admit such a blunder.
AMRN has never been truthful or
transparent. I am genuinely happy
for your wife's great outcome.
drrc: If I was able to tell you I would. That
blustering Schmuck JL has repeatedly BS this Board
for over three years. In my business there is confidential
information, and I respect that. Ask EPADI if I didn't
meet with Waxman and was able to convince him to get the
FDA to put the rescinded SPA put back on the table. Why
would FDA DO THAT ONLY TO rescind it again. I do know
some of the facts, and AMRN Mgmt stubbornly refused to
compromise. Their mindset was ANCHOR, and FDA pulled their
plug. Take a hard look at Mgmt and it should be obvious
that they didn't have the leadership to do the right thing.
Why do other Mgmt teams succeed ? because they execute !
Why do they receive such large compensation packages ?
Because they take their Co's to the next level and build
shareholder value. AMRN Mgmt destroyed shareholder value.
Take a look at the chart, that AHOLE JL should be able to
see a death spiral. Some folks on this Board remind
me of the Japanese soldiers who didn't surrender for 20
years after Japan signed an unconditional surrender. I have
nothing to gain by misleading the good people on this site.
JL recently got run out of Boston, and is now in Florida. Ask
him why ?
INVESTOR: Don't know how to respond. I was far from
a winner. I am not harassing anyone. JL has been a
continuous problem to this Board. As an MD I have a major interest
in Vascepa, as I believe it is an outstanding drug. I come
back to the Board every 6 weeks or so just to see what's
going on. I'd love nothing more than to see Vascepa become
a huge success. My connectedness to Industry and Wall Street
allow me a very different POV. I believe hearing the truth
is the key function of a message board. That said, look over
my posts. I am just trying to open some eyes as to what happened,
as opposed to the mythology I read on my infrequent visits.
JL: You're still pumping out the same Cool Aid
that caused this Board to lose 10's and 10's of
millions of dollars. You know that the $10M that
JZ x2 sent the message that brought in the shorts
that with other foolish mistakes, GIA, not
compromising with FDA following Waxman getting the
SPA PUT BACK ON THE TABLE. All Agency wanted was a
compromise, they didn't want to reinstate Anchor
until after RE-IT results. They were willing to
allow AMRN to market Vascepa for Trgs >200mg/dl.
but to clearly state that there is no proof as yet
that it lowers CVE's. You also are all to well aware
of my background. You still can't allow yourself to
think that your brilliant mind made a mistake.
Chica: You'd best check again as that's exactly
what happened. With the right CEO and Senior Level
Management team , this marvelous drug . could have
made a difference. I don't chose to argue with you,
but do a Soul Search and make sure you're not drinking
the Cool Aid.
A Friend
HDGabor: Basically the efforts of EPADI and Waxman
got the SPA put back on the table. They wanted a win/win
ending. They wanted to change the SPA to allow AMRN to
market Vascepa for TRGS >200mg/dl, make the RE-IT results
decide the outcome of the ANCHOR original SPA. That way
both sides would save face. Thero stupidly stuck to his
guns about reinstating the ANCHOR SPA, and never thought
that FDA would blow the whistle on the Friday before
MLK weekend as they couldn't budge Thero. He is still
trying to get the SPA reinstated, according to the CC.
As for FDA, when they blew the whistle at the end of
Friday negotiations, it was Game Over.