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continued: fluent in FDA Speak and on that fateful run up to the
MLK weekend, plain and simple blew it. Those are the facts in spite of your prosaic attempts to refu8te it. Remember my dear.
old friend, "only the guilty flee/ When no man pursuith"
Jesse: For the sake of truth, Waxman did get the SPA put back
on the table. Unfortunately for all on this board,. AMRN simply
weren't flue4nt in
JL: Of all people Jesse, you know exactly what happened.
Half of the Hedge Funds involved in the name knew about
what happened. I heard it from colleagues and you know
that. For the King/Guru and lousy Investor, you feel
threatened by the thought that possibly someone else
has a better take than you did. You ought to be ashamed
by your outsized Ego.
KIWI: July 12th was the approval date for Vascepa. R-IT, hadn't
started enrolling as yet and Anchor was considered by all to be
a slam dunk. JZ was the definition of an a..hole, and in point
of fact his still being a Director, is one of FDA's major sources
of animus toward AMRN. If you recall, he was not allowed to attend
the Anchor ADCOM. If there was a hint or a whiff of they're knowing anything, they would have been guilty Insider Trading. The FDA would have nailed them. You are too generous to these two destroyers of SHAREHOLDER VALUE.
JL: I respectfully disagree with you. It is done
less frequently today than the earlier days of
Biotech, where Mgmt needed to make a statement of
support for their beleaguered shareholders. The
paradigm shift occurred with such a large number
of Biotech's being revenues and earnings positive.
Just recently their was Insider buying in some
large Cap Bio, as a statement: Underscoring that
the share price was a bargain. JZ didn't just sell
"some warrants' but $M'S worth of shares into the
approval of Vascepa for the Marine indication. Several
Directors did as well. JZ is one bad apple, and his
reputation in the industry is down there with
"The Whale Shit".
BB: Great that you sent it out to all Republicans. That said,
you're missing my point. Both Rand Paul and Ben Carson are likely
to make a Presidential run. This puts them in a position of massive TV exposure. All we want is for them to start talking
about Governmental corruption, fraud, and malicious discrimination by the FDA. Two Physicians speaking to this gives
them great talking points to millions of Americans. Ben Carson will do the same thing, and in addition bring up the point that
an African American President is supporting this corruption at the expense of millions of African American Lives. That Williams
gets huge public attention and brings the media on board. I do
believe this could cause all sorts support that AMRN has never had. More effective than a shot gun mailing to the entire Republican House.
BB: Btw, some on the Board might not be aware that Ben Carson MD
is an African American, and Chief of Pediatric Neurosurgery at Johns Hopkins. My apologies to those of you already familiar with
Ben Carson.
Hey BB: Just a thought, but have you thought of contacting
Rand Paul. As an MD, Ophthalmologist, and Libertarian, I
suspect the AMRN story would give him more talking points
and Anti Big Government rhetoric than he currently has. Might
I add Ben Carson to the list. Both of these guys would love
nothing more than having a blatant miscarriage of FDA justice,
to rile the public and put some real heat on FDA. These guys will both understand the story, see the sham of ADCOM and hopefully give the FDA another orifice to use. With CV events
higher in the African American Community, Ben Carson would be
all over it. "Government Sponsored Medical Racism" Catchy if
I say so myself. Go sig em !!!!
bundyelvis: I completely disagree with you on myriad levels.
BIO and PHARMA, the Industry Organizations for Biotechnology
and Pharmaceuticals have two of the more powerful lobbies in
DC. That said, the very last thing they would allow or not try
to stop, would be a Price War in our respective sectors. I am
aware of this first hand. My guesstimate for ABBV pricing is
$80K-$85K. Do take into account that both IO's fought the administration's ACA on negotiating pricing of drugs. It was so important that they agreed to an $80B rebate (Kickback) program over the next decade. I would doubt that Abbott would cave in on ABBV's HCV drug.
Dew: We meet in strange places. The ESRX move today on not
including AMGN's Aranesp and Epo in their formulary; IMHO doesn't
have a meaningful read through for GILD. There are less expensive
choices, ie, Procrit and some of the IV Iron infusions, with similar efficacy. With ABBV's drug regimen, the use of Ribovarin,
is not an acceptable alternative to Hepatologists, and I believe
GILD will command 75-80% of HCV market share.
Share Price: It is my opinion that there has been significant
profit taking in Belle Weather stock that has appreciated 36%
this year. That said, there is a technical factor involved as
well as an overhang related to ABBV pricing. Firstly, the stock has tested support at 100 5x. In my experience, the more often
a stock retests major support, the greater the likelihood that it
will breakout to the upside. IMHO, ABBV's HCV regimen can't treat
Genotype 2, 3 or 4, and to most Hepatologist's using Ribovarin
is something they go to great lengths to avoid it. I believe
Harvoni & Sovaldi will capture and maintain at least 75% of
market share.
sts: The app is Epocrates and is easily downloaded. It is
much more user friendly for Physicians than lay people.
It is extremely helpful.
Jl: Unfortunately Anthem Blue Cross of Ca doesn't cover
V. One needs prior authorization, and there is a $120
co pay. Lucky you !
HD: This Board not withstanding, the largest demographic
in need of Vascepa are Seniors, and Medicare doesn't cover
it, or at least denied my prescription. When and if Medicare
ever covers V the scripts will go through the roof. Think
about all the age related diseases, and with the exception
of Cancer, all have inflammatory etiologies, and or components.
Zum Is Go Seek still on board ?
JL You're absolutely right. I was trying to infer
that FDA did not consider it for approval. Not
the first time I poorly articulated my self. Thank
you for your help. I was just attempting to state
FDA sadly never considered it as a comparator re AMRN
Zum: Jelis was a meta analysis trial, and completely inappropriate
for comparison. FDA doesn't accept Meta Analysis Data for
approval. Improve-it was a prospective, multi center,
randomized, blinded , controlled trial. Apples and Oranges.
Btw, it is the first FDA acknowledged trial showing positive
CV outcomes since the early days of Statin Studies. Albeit,
AZN did a non sanctioned outcome trial in 2006 which IMO was
cherry picked, and only AZN did the data mining. I've always
wondered about the real validity of that trial. Unfortunately
for AMRN, it underscores that LDL-C is the only Lipid metric that
AHA/ACC accept for Lipid lowering. Btw, PFE and AMGN lowered LDL-C
between 58%-72% with their PCSK9 drugs. FDA stated they would be approved prior to starting a post marketing PH IV Outcomes trial.
Dew: What is your opinion of the PCSK9 drugs, and
their impact on Statins. Do you have an opinion
on CEPT drugs ?
BB: I hate to disagree with you, but Dew is spot on.
It has always been my opinion as well. Historically
they never back down, Remember that the highest levels
of FDA agreed with the SPA being rescinded.
ggwpg: Million's of Diabetics do it daily. It's
sub cutaneous, just pinch your love handle and
inject a small needle. No big deal. The side
effects are known and not particularly a problem.
Read up on the group (PCKS)
Improve it data will be out Monday and I doubt it will
show benefit. I also feel that it probably won't show
any harm either. The event is irrelevant as Zetia will
stay on the market, but will be replaced by PCSK9 drugs,
as they are so much more effective in lowering LDL. The
REALLY big story in the background is AMGN suing REGN and
SNY over patent infringement of their PCSK9 drug. Amgen
became so enormously successful over the last 30 years
because of their success with patent litigation. They are
tossing a shutout on Patent infringement cases, and probably
will prevail here as well. They are really a Law Firm with
Fermenters. Either way outcomes trials are the future of
Cardiology drugs. It will have zero impact on AMRN
ggwpq: Nonsense, JT's purchase was Tokenism at it's pinnacle.
The take away for the Investment Community, though I doubt
any institutional investors are still paying attention, is
it's too little too late. He may be a bean counter, but
he never misses an opportunity to miss an opportunity
STS: I believe so ! DNDN had a very expensive, lousy drug,
with marginal benefit, that gave an extra 3.8 months survival,
a lower PSA, and no relief of pain, or metastasis to bone.
The Co repeatedly shot themselves in the foot, never listened
to the FDA on the suggested endpoint, took 4 years to do so to
finally get an approval. I shorted the stock on the day of approval as this was an obvious disaster waiting to happen.
My only mistake was covering the position too early. What's
ironic, was that since Provenge was the first Immunotherapeutic
ever approved, every IB had Strong Buys on it.
alt: It's nothing personal for Lazard, or in any way
an endorsement by them of AMRN. Their just Investment
Bankers trying make a $.
Kiwi: I am aware of that, and personally feel there are
no safety issues with Vascepa. That said FDA is malignant
when it comes to AMRN. There's a buzz I heard going back
to adcom, and have heard of some issues somewhat recently.
I wish I could pinpoint it, but I can't. The FDA has done
this in the past with company's they've been contentious
with, even without any safety signals that would raise
legitimate concerns. The relationship between AMRN and
FDA is as nasty as I can recall. The 30,000 patients on
V without safety concerns is a big positive. That said,
in a different indication, FDA can and does make arbitrary
decisions. The AMRN SPA decision was discussed at the highest levels and the decision to rescind was upheld. I believe
that AMRN dropping further appeals was smart as it could be
a step forward in making nice to Agency. Hopefully, this
will allow for an improved relationship. The only reason I
brought it up is that there apparently is precedence for this
in outcomes trials. I can't give you specific names, but it
is another potential blind side hit that FDA could deliver.
The DSMB only looks for safety issues to keep the trial blinded.
This is by far and away the most vindictive Biotech story I can
recall after 23 years. A few exceptions are an old Boston based Biotech named Organogenesis, and a San Diego based Biotech by the
name of Advanced Tissue Sciences. I believe the Co would have been well served getting JZ to resign from the BOD. That would
help making nice for sure.
Zum: Statistical significance is expressed by a P
value. Less than .05 is significant. My concern is
that even if it's obviously significant, the FDA's
main concern with V is safety, and they may want
R-IT completed for the large number of patients
demonstrating no safety issues.
couldbebetter: Thanks for your nice words. Unfortunately
the current BOD still has JZ on board. That said, all
Management and the BOD are interested in is getting their
paychecks and waiting for R-IT results. They have all sold
enough of their shares that they are all set financially.
They have never done one thing that has been in the interest
of their shareholders. They still haven't fully enrolled the
R-IT trial, which IMO makes super positive results more difficult.
In point of fact they sold their shares into the Marine approval. In the Industry, that is unprecedented. I have no interest
in getting involved with this "Gang That Can't Shoot Straight".
But I do appreciate your comment.
JL: You are the resident Bomb Thrower extraordinaire .
Medical information disseminates slowly, more slowly
than is acceptable. Why didn't grasp your concepts ?
They are strong believers in Statins, which in spite
of your feelings are still the number one prescribed
class of drugs in Cardiology. I gave you your due.
You will most likely be correct about the Inflammatory
Etiology of CV. That said, the powers that be obviously
disagree . Don't let your narcissistic bent get in the
way of what's happening now. Your timing wont be Scientifically
Proven until R-IT is proven to be statistically significant.
I know this pisses you off, but those are the facts. According
to the AHA/ACA Trig lowering has never been proven to reduce
CV events.
JL: Your comments are denying the facts. I never
suggested that the AHA/ACA, FDA, or the MD's in the
trenches are retarded, "Your words" not mine. For
the
Dew: The answer is simple. They initiated coverage
when AMRN was an up and coming Co with a drug close
to approval. AMRN is still in their Universe of Coverage,
and like all IB's they will do what they do best. Investment
Banking. Sooner or later AMRN will do a raise, or if R-IT
works out do M&A.
Kiwi: This was for nofan. I stated what I believe
to have happened. Just my $.02 worth. It's called
freedom of speech ! That's why we voted yesterday.
I didn't attack him or any one else. I gave him credit
for his knowledge and tried to get all of us to understand
how long it takes to disseminate Medical Information. I
started posting that almost 3 years ago when most of
the Cardiologists I knew never heard of Vascepa,
or really believed that Trigs cause adverse CV disease.
I initially thought that it was because that AMRN had no
Reps in the Beverly Hills, West LA area. It then became
obvious to me that Medical Education was behind the times.
The ACA/AHA, FDA, and Physicians in practice still
believe LDL-C is the culprit. The ACA/AHA didn't consider
Trig lowering agents ( Vascepa) Non Statin Lipid lowering
Agents. I'm a Physician and I too believed the Science.
I too drank the Kool Aid.
Kiwi: This was for nofan. I stated what I believe
to have happened. Just my $.02 worth. It's called
freedom of speech ! That's why we voted yesterday.
I didn't attack him or any one else. I gave him credit
for his knowledge and tried to get all of us to understand
how long it takes to disseminate Medical Information. I
started posting that almost 3 years ago when most of
the Cardiologists I knew never heard of Vascepa,
or really believed that Trigs cause adverse CV disease.
I initially thought that it was because that AMRN had no
Reps in the Beverly Hills, West LA area. It then became
obvious to me that Medical Education was behind the times.
The ACA/AHA, FDA, and Physicians in practice still
believe LDL-C is the culprit. The ACA/AHA didn't consider
Trig lowering ( Vascepa) agents as Non Statin Lowering Agents.
I'm a Physician and I
too believe the science. We all drank the Kool Aid
nofan: That was your best post in all the years we've been
on and off this site. You are spot on almost every point.
I've been in Bio Pharm and they are not the bogey man. There
is something slightly off in our perceptions. GIA was no
more no less than after 6 months desperation set in and
JZ had no other choice. He was not stupid. The point of the
Science goes back to what I posted over a year ago, We all
drank JL's Kool Aid , and his knowledge of Lipidolgy, brilliant
as it was , loomed years away on the horizon, and dissemination
of what he and some others understood have escaped the AHA/ACA,
the FDA. and those Doc's in the trenches. We were outraged of
being so taken advantage of that we couldn't see the forest
from the trees. JL poisoned the well !
one offer has been tendered according to Management,
No attempt to out license Vasceepa at the Euro Partnering
Meeting where most deals involving off shore rights are
done. Dropping the FDA's rescinding of the SPA was their
ace in the whole. Having to wait about 3 years for a
pay day. The IP isn't clean enough to do a deal should
an offer come in. Adding up all the difficult questions
should give one pause for thought. I've been in the business
for 23 years and I've never run across a situation quite
like this. It seems to this observer that their are some hard questions that no one, least of all the Co is able to shed
clarity on. Yeah, we can blame the FDA for everything, but
I doubt that's the case, Yes, FDA really stuck it to us. I've
heard through the grape vine that FDA's argument based on new
science was cogent and passed muster high up on the FDA food
chain. Why are so many of us still convinced we will prevail?
STS had a great post yesterday re: HF or VC's stepping in for
"chump change". Why hasn't that happened ? I personally approached
Icahn's people and one other activist I know. Neither were remotely interested. Have we all fallen emotionally in love with a drug, and have obfuscated the reality. I wish the hell I had
some answers. There are some very bright people on this site, and
I'd love to hear a few rational, non emotional answers as to how
they reconcile all the holes in the AMRN story.
Hypothetical: I did listen to the CC and was somewhat
surprised. Basically the science makes sense. That said
there are some hard questions everyone should ponder.
Not
Hey Dew, Run into you in the most unlikely places. Glad
to see you riding a winner. As per ABBV's drug, price alone
won't be the sole determinant of success. GILD is already
discounting Sovaldi to the VA system at $61K. They are also
discounting to other major Institutions and third party
distributors. Physicians will be loath to Rx for the ABBV
drug because of the pill burden and most importantly because
one drug in their cocktail is Norvir, an HIV drug with nasty
side effects. As for Harvoni, (reasonably priced at $66K) "One Pill" a day with a squeaky clean side effect profile will dominate market share. GILD has proven their ability to dominate during the AID's wars, when they went toe to toe against BMY, GSK, MRK, etc.
FYI, Friday,the market seemed to be sluggish on a day that the Dow, S&P, made new highs. This is one thing that I watch for. BBH and NBI actually down on record day. AAPL not exactly leading the new highs. Looks like institutional distribution of their winners (GILD)under the smokescreen of new highs in the averages.
The National Institutes of Health is starting a North American trial of pitavastatin from Kowa Co. Ltd. (Nagoya, Japan) to prevent cardiovascular disease in HIV patients. The double-blind, placebo-controlled 6,500-patient REPRIEVE study will last six years and will enroll HIV patients with no known cardiovascular disease and low risk factors.
Kowa said HIV patients have a 50-100% higher chance of developing cardiovascular disease compared with the general population. The company is donating its statin and is providing undisclosed funds for the study.
JT stated that there was no offer for the Co as a matter of
Public Information. The very same question was asked at a
breakout session at a Leerink conference. Joe Schwartz is the
AMRN Analyst. You insist on showing us your lack of Industry specific, Company Specific, or stock market specific knowledge. I'm actually trying to give you facts so that you stop spewing
your ignorant BS.
as the Data Safety Monitoring Board, DSMB. Why not
go back to the hole you crawled out of instead of
continuously making a fool of yourself. Many Biotech
Co's have had Senior Level MGMT take 50% of their
salaries, and in some cases, suspended their entire
salary until their cash starved companies resolved
their cash crunch. You come off as an arrogant know
it all when in point of fact your knowledge is sorely
lacking.