Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Bio: The choice is like choosing between Cancer and Ebola.
Bio: You mean the patent attorneys filed and secured all the issued and pending patents. JZ caused the Co unprecedented harm.
JL: Your literary flair has been appreciated by this
observer going along way back, and are commendable.
I disagree with you on what JZ said "didn't matter".
As you are aware, I am involved on WS , and when
others as I did, following the sale of stock spoke
with IR and asked about whether any offers were made
or received and presented to the BOD, the answer was
always 'No". During the subsequent few months a large
number of HF's exited the stock as they felt the CEO lied
and executed the old pump and dump. Further more we lost more
than half of the holders who had reportable positions.
This explains why the stock reversed from $19, and settled
around $7/sh in 5 weeks. This included SAC, Fidelity,
T Rowe Price, and Orbimed among others. I won't argue with
you about the semantics of "offers" vs parties, but I am
just as certain of my recollection as you are of yours.
Best
Your literary flair is to be commended. The reason why
sts66: I;m surprised at you . You are fully aware
of professional confidentiality.
ladavis23: I completely agree with your negative opinions
about management, and could expound upon this at greater
length . That said, I am in a situation where this is professionally impossible for me to do. The negativity on
the part of the Investment Community (WS) is an old grievance. Many HF's were involved in AMRN when JZ did his infamous "Pump and Dump" routine driving the stock price up to $19 and change, and then selling $M's worth of shares."I have more offers than employees" was an exact quote in an Industry Business Weekend edition made during a breakout session at an . His selling
$M's more into the Marine approval is unprecedented in our Sector. HF's have long memories and basically give a Biotech little chance to regain their credibility. The Baker Brothers have had more than their share of failures as well as some spectacular winners. Removing JZ as CEO, but permitting him to stay on the Board has allowed the negativity to persist. JT is
at best an accountant, with no training in science ,let alone biotechnology. He has a lack of prior leadership experience, and less leadership skills. Your comment about JZ playing Cyrano de bergerac to JT has been around for several years. I have no personal knowledge to confirm this, just a high index of suspicion. I am long AMRN, and believe the two Court wins, and
a fine drug will hopefully win the day. Changing management will not happen at least until full resolution of negotiations with FDA. One poster erroneously gives management Kudos for the wins in court. I give their legal team full credit and JT a B for supporting their selection.
sts55: Confirm ! Not taking oral or inj Steroids to avoid
injection site reactions,(PCSK9) as I've not had any. Probably
for those occasional patients that get them. Not generally
used.
sts66: Not sure what you mean by "oral steroids by injection"
I believe it's just REGN as of now.
My mistake: A Co can not sue a Govt Agency (FDA)
for damages. This means that the delays could be
problematic, and I have no idea what on earth they
could be negotiating for. My conclusion: The FDA
doesn't give ice away in the winter time.
mog: I hope you hold your breath when it happens Mogwash.
JMO: I would think that it would be easy for FDA to expand
the Marine label to include Anchor metrics, and not be pushed
into touching the thorny issues regarding rescinding the SPA
ETC. Lovaza is the precedent. I still believe that the delay
is plain and simple due to MONEY, how much in damages should
AMRN receive. I also assume that the Judge is not going to give them another extension.
sts66: To my knowledge AMGN's PCSK9 has not been incriminated
with CNS infections. They are apparently focused on REGN/SNY's
PCSK9 which apparently opens the BBB and a few infections have occurred. That said, I have no idea what will be uncovered,
but it didn't stop the PBM from allowing me to switch from
Livalo to AMGN's Repatha . CVS has an exclusive on Repatha,
and it has not come to my attention that it is difficult to
obtain. "A Doctor who treats himself has a fool for a patient"
I am now relying on PCSK9 (Repatha)and Vascepa, which seems like
an ideal combo to this observor, barring further evidence of AE.
zum: Quoting Cafe Pharma is never reliable. On the flip side
10's of thousands of patients have been enrolled in the soon
to be completed Outcomes Trials, and the various DSMB's would
have stepped in along time ago. AMGN's trials will be reported
on in early 2016. IMO PCSK9 Drugs are having a slow, but expected
ramp, but all the PBM's are covering this remarkable new class.
Assuming the outcomes trials are positive, I would predict that
they will eventually replace Statin's. The ideal combination may
just be PCSK9 + Vasceepa
mrmain: The Legal team gets credit for the NCE and 1st Ammendment
wins. I'm not really sure of the metrics that you are using to
evaluate the Chinese deal. Please share with me the wins other
than Legal that JT could claim victory for.
Benny: Au contraire my friend. He may have taken over a 2-14
team, but he was a rogue hire. After all he had no prior
coaching experience, certainly not on the level he entered,
had no offensive coordinator, and was obviously the least
experienced X's and O's guy. What has he accomplished ?
The team is still 2-14.
marzan: One thing to keep in mind, the Court will not
allow this to go on very much longer. The Judge is kept
apprised as to the negotiations, and He has the final
say as to how many delays he will permit.
marzan: They can't make any statement until all
the loose ends are tied up. That's all what the Court
will accept. You can't bifurcate parts of a negotiated
settlement
Historical perspective: In following FDA for over
20 years the primary thing they play hardball about
is Money. I would guess that the negotiations
have been completed with the exception of AMRN
seeking attorneys fees and damages. How it ends,
I have no clue. The FDA does throw Quarters around
as if they were Manhole Covers.
addendum: FDA would easily able to get Congress
on board as it would not be in either party's
interest to see massive off label sales. I for
one believe that trumps all other issues. JMO
oneragman: I don't agree, as the FDA, as we've been witness
to during the past 3+ years, can really do whatever they
choose.
noelan: That would be my guess, but it's the only pragmatic
way for me to explain what's going on. Remember, just a guess.
zum: If I were AMRN's legal team, that would be
exactly what would placate me to recommend that
my client drop the Temporary Injunction. It is
very interesting as a point of law for the Agency
to prevent mass off label use of most all drugs.
BB : If I were to think about the negotiations between
AMRN and FDA, the most important point AMRN can get
would be for the NCE to enter the OB in January, and
run forward for 5 years. That would really represent
"Making Amends" and a huge AMRN victory. FDA can say
whatever they want to justify doing so, as they make
up their rules on the fly.
zip: My point was that IMO was why reducing Trigs is so
questionable in Medical minds. I also believe that when
the AHA/ACA came out with their new guidelines, not
including Trigs, in the entire guideline paper, Anchor
was turned down as I've been posting since 2013.
Zum : Did it ever occur to you that R-IT could be strikingly
positive and still have nothing to do with Trig reduction.
I'm of the opinion that reduction in BioMarkers that measure
inflammation *(CRP)etc are the key components of an Inflammatory
Disease. Could explain why scripts are low and everyone from
the AHA/ACC, FDA and Doc's are skeptical about Triglyceride
reduction.
inflammatory potent activity that lowers all the Cardiac Bio
Markers and this ant-inflammatory reaction lower AE's ?
D
Gabor: With the two Court victories, and a December decision
on resolution, which has to go AMRN's way, I seriously doubt
any shorts are still significantly in the game. In checking,
the short interest has been decreased. A good thing, though with a positive decision, it would have been nice having them cover their positions on a high volume day.
Mog: I've known the Baker Bros for over 20+ years
and they do excellent work, and are attracted to
Co's that have had their stock beat up, a good drug
and see a path forward. Preferred stock is better than
common in many respects and allows them more leeway
in helping management snatch victory from the jaws
of defeat. PS. This management is learning, but are
really learning on the job. They need all the help
they can get.
Mog: I've known the
Gabor: It's extremely unfortunate not to pick on
someone your own size. The shorts are very much
part of the game. I hold them in contempt with AMRN;
however, AMRN management, at the time JZ was CEO,
brought most of it on himself by his pump and dump
strategy to optimize his own fortune at the
expense of the shareholders. All roads lead to Rome.
After his "I have more offers than employees" quote
in the press, while selling his own stock at about $19 sh,
he compounded everything on the Marine Approval. It is
unprecedented in our Industry for the CEO and BOD to sell
millions of dollars worth of stock the morning following
an FDA approval for the Marine Indication. This is all
fact and well documented. Behavior like this attracted shorts
to the table in droves. They believed , and rightly so, that all
the Mgmt. wanted was to sell the Company and not focus on marketing an excellent drug. GIA was a death knell, and unfortunately we have a thoroughly depressed share price, and everything depending on R-IT results. It's a bloody shame because Vascepa is an excellent drug that got mugged on it's way to monetization. I don't believe there's any grounds for a law suit, but I'm a Physician not a lawyer. In 22 years in this business I can't recall shorts being sued . Could have happened, but I don't recall it .
ladavis: I basically concur with everything you
so ably noted. There is a saving grace. Any offer,
and the Co has never received one, has to go to
the Board and an 8K filing must be done. JZ was
pumping and dumping, which is why FDA became
antagonistic. I believe with the Baker Bros. you've
got an interested/investor party that JT must deal with
should an offer be received. They are after all not V
cultists but two smart guys who want to make money.
Mog: It's not public to a holes.
The deals that get done always come as a surprise,
unless preannounced as PFE / AGN. You would be the
last person to hear anything as it is appalling as
to your lack of fundamental information. That said,
I'd bet you'd be among the first to cover your short
position.
BB: Another point overlooked is that Kowa's Statin
is IMO the best tolerated Statin re adverse events,
muscular skeletal issues etc. From a numbers point
of view it is as efficacious as any other Statin
with the exception of Crestor. Subtracting the number
of patients on Crestor still leaves 33M patients who
would be best served taking Vascepa with Livalo, 2mg
or 4mg. Kowa would find that a marketing piece of cake,
should the interest materialize.
dude: Well said and honestly put forward.
My experience on the street has been that
the paid short has a lot of laughs along
the way, but is always denied the last
laugh. That's ours, but we don't look at it
that way. It's just the fundamentals we
believed in , prevailed
chas: What most folks on the board are not taking into
account is the predetermined Hazard Ratio and Power of
the R-IT Trial. This was negotiated with FDA approval.
Though it won't affect the number of events, the
enrollment number must be 8000 patients. It will affect
how DSMB and FDA evaluate the interim look should there
be one. That the first 2000 patients averaged Trigs of
150 mg/dl, there could be a delay in getting the results.
The 8000 patient number is more important than most think.
RAF: You always comment though you are the least
informed poster on this site. Why don't you try
to learn something before you get a terminal case
of hoof and mouth disease.
Zum: It appeared in a private publication called
Sleuthing Health Care about 3 hrs ago. No details
mentioned other than use with Livalo. If I see
anything else, I'll post it.
Kowa & AMRN: Just heard that Kowa is interested
in acquiring AMRN. No details. Not sure how I feel
about it, though any thing that smacks of BO is
encouraging.
Kiwi: The first CEPT came from Esperion (ESPR) back about 2002--04
They sold it to PFE after a positive PH II Clinical Trial for
a little over $1.1B I remember because I thought management was
superb. All the other CETP drugs have failed, a couple recently,
The same guys are back with a second gen drug supposedly fixing
the mechanism of action. The stock went through the roof getting up to at least $114/sh The stock has sold off enormously and now sell'S for about $26/ sh . At this price I feel the valuation is reasonable, and this management team just might pull it off.
I believe this drug lowers LDL and raises HDL. interesting to see
how it goes.