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Bill: You are correct, I did say that. However,
the Agency did have it in for JZ, and they did
behave shamefully. They had made up their minds
before the panel meeting. How much you attribute
to antagonism, the changing AHA, ACC, guidelines,
how the latter does not consider a drug that lowers
Trgs a non lipid lowering agent, w3ho knows ? JZ
did not attend the ADCOM meeting, why ? For the most
part IMO the Co was put together to sell the franchise
after the Marine approval. They were not qualified to
do anything else, and they didn't do one right thing.
GIA was a disaster. I also said that enrolling Pts
always slows down at the end, and that the earliest
they would have results would be 2018.
Chica: Check, unfortunately it's true and the
company has admitted it and after the first
2000 patients, changed the enrollment criteria
to >200mg/dl. Where Mgmt again screwed up was
in accepting that in the first place.
Williams: We all got suckered. Though I cut my losses
a long time ago. The FDA isn't the culprit as I have been
saying for the last 2+ years. AMRN Mgmt is directly responsible
for this fiasco. From JZ antagonizing FDA, selling stock into the
FDA approval of Vascepa, and doing a pump and dump number by stating publically that he had more offers than employees, to GIA; Mgmt (THERO)not compromising when the SPA was put back on the table ETC, ETC. All he had to do is was agree to revise the SPA, which he refused to do. He is still fighting to restore Anchor, which I doubt FDA will ever do. Don't forget Trgs are not considered as a target metric that Agency feels is relevant in CVE's. I guess if I still owned stock, I'd be in a quandary as to what to do today. Reminds me of WW II, when many Japanese troops refused to surrender for as much for as long as 20+ years following Unconditional Surrender. Also recall AMRN stated that
they had enrolled 6200 pts in RE-IT Trial 8 months ago. So in
that period of time they only enrolled 400 Pts, that's pathetic.
The first 2000 Pts were enrolled with Trgs at or about 150mg/dl.
This is a very sad course of events, and I seriously doubt that
they will have results until 2019. Are you all committed to wait that long ? However
James: I was singularly unimpressed by the Jellis study.
Difference in population groups, dose of EPA, and not
particularly elevated Trgs. My own sense is that AMRN
should have used different endpoints with Anchor. To seal
the deal they should have focused on the reduction in
inflammatory markers, as knowledgeable Cardiologists know
that Inflammation is the etiology of Coronary Artery Disease.
BTW, I believe that holds for DM as well. The ACC and AHA
would not have been able to negate that point. An analogy
would be tantamount to a Diabetic presenting with a blood
sugar of 200 and the Doc stating that elevated blood sugar
is the cause of Diabetes. The same with elevated Cholesterol.
I personally believe that inflammation of the intimal lining
(Vasculitis) allows hydrophobic Cholesterol to stick to
the inflammatory site, rather than just being naturally
eliminated. With your stated concern about DM, Statin and
Vascepa works best in that demographic. (low HDL and elevated Trgs.
James: Name some other options for Chronic Pain Mgmt
Rx's that decrease the pill burden and would have a lower
Abuse Potential. Why weren't you strongly opining on PFE continuing to sell Sudafed, the number one ingredient in
"Speed". It seems we're arguing how many angels dance on
the head of a pin. Let's agree to disagree
James: You just don't get it. It was approved because
Zohydro is the only realistic option for Chronic Pain
Management. If one were predisposed, he could snort Sudafed
or anything else. It just adds another arrow in the quiver
for MD's to have a long acting, non Tylenol, extremely efficacious
drug for an unmet medical need. Are you an MD ?
Continued: Pain. PFE huge success with Sudafed, was in part
due to the selling of bulk amounts of Sudafed which was used
to make "Speed". The REMS with Zohydro are pretty formidable.
Basically in our convoluted society, you can snort almost
any Opioid tablet. Everything can be crushed. Look at AMRN for
example.
James: If you had chronic pain, and pre existing Liver disease,
You would have very few choices as most of the Oxycontins contain
Tylenol. There is nothing marketed for Chronic
I strongly disagree: Zohydro is sorely needed as a Rx for
chronic pain management. It has a lower abuse potential, as
it has a slow delivery system, which translates to fewer "pain pills" It is not stronger than any of the Oxycontin's but lasts considerably longer. Zohydro doesn't contain Tylenol, which is contraindicated in patient's with Liver disease, (about 20%). As an MD, I find it ludicrous that one would be upset with the first Rx for Chronic Pain Mgmt.
nofanofthis: I unfortunately agree with you 100% percent . BTW, I haven't been on this site in 3 months and I guess I'm the new kid on
the block. With EPADI, being a constituent of Cong Waxman,( living in Beverly Hills ) and having helped fund some of his campaign's , getting a meeting with him was not too difficult. He really helped
along with Senator Grassley, in getting the SPA put back on the table, only to have Mgmt blow it. I was reading some of the posts
on the site and I am amazed at how many uninformed Newbies are posting such BS. They don't know whats going on. It's frustrating.
I am not going to come back and read this foolishness. I wish you the best of a lousy situation. Good luck !!!
concapk: You're flat out wrong. Black Box was a rumor which
turned out to be incorrect. All FDA wanted was a revision of
the Anchor SPA with labeling restrictions, nothing odious.
There were other issues, but bottom line AMRN would have been
able to market Vascepa for Trgs > 200mg/dl. Had a real CEO been
there, a compromise would have been worked out. The problem is
AMRN was put together for a quick sale following the Marine approval. The management team was not put together to market the
drug and deal with FDA. They maybe the most incompetent Mgmt Team
in the Biotechnology Universe. Why don't you try reading Thero's
resume.
Bar exam. Basically this spawned the PI business and all the subsequent Parasitic areas Lawyers have intruded into. Reason,
too many lawyers and not enough normal ares of the Law. Those
Law Students graduating Harvard, Yale, Stanford, Michigan, Princeton, etc were first round draft choices, leaving the for
profit grads to innovate Parasitic Law. I published 2 papers on this
very point.
north40000: I am not disputing that the Law Firms are
first rate. As Gertrude Stein might have said,
"A lawyer is a lawyer is a lawyer"
Nothing personal, just my opinion based on my own
and others experience in Personal Injury, Product
Liability, Malpractice, Divorce, Workmen's Comp etc.
As a Physician, I view the Legal Profession as a
"Parasitic" Profession. Think of how they have
metastasized into our normal lives just to make
money. The problem is, unlike the Medical Profession,
which standardized the curriculum for all medical
schools, eliminating those for profit Medical Schools,
who did not comply and standardize their curriculum.
The AMA did this in 1942 at which time there were about
1400 Medical Schools. The accredited schools were cut down
to 65. This allowed for the National Board of Medical Examiners,
enabling any Medical Senior who passes the exam to be licensed
in any State in the union except Florida. The ABA had the same
issue arise in 1946, and they reused to standardize the curriculum
of all for profit Law Schools. The number of Law Schools proliferated, and Law School grads have to sit for each state
mrmainstreet: Until and unless an Activist Share Holder
cleans house ( Gets rid of the BOD and Mgmt Team it is
dead.
north40000: Did these Law Firms ever run a Biotech
Company ? No !!! They're hired guns trying to use
the Legal System to manage a medical controversy. They
are only concerned about "Billable Hours". Ringing up
the cash register, nothing else. Correction, I'm sure they
feel they can win. That said, they're still hired guns.
mrmainstreet: What else can they say on the CC.
They were ignorant and not fluent in FDA Speak.
Therefore they made a Rookie mistake.
kvenne: I have put in close to 4 years with
this Co, and believe Vascepa is the real deal.
It is the only Cardio Vascular drug that significantly
and statistically lowers the Lipid Inflammatory Markers.
The etiology of CardioVascular Disease is Inflammation,
not Cholesterol. With the Coronary Vessels lining inflamed.
Cholesterol sticks to the site of inflammation, and causes
an elevated Serum Cholesterol. Think of a Diabetic with a
Blood Sugar of 200md/dl. The analogy would be to blame
the elevated Blood Sugar for causing Diabetes.
ladavis23: He's in over his head and doesn't have
a clue. He's letting the attorney's run the show.
BIG MISTAKE !!!
ziploc: I have been stating that on this site
for the 41/2 months. Check out his resume. He
has never had any real Mgmt experience. You're
correct, we need a real CEO and BOD.
rtc110:You are new to the board, and are not aware
of my meeting with Waxman seeking his aid for AMRN.
AMRN will acknowledge that. He got the SPA put back
on the table. I DON'T SPECULATE PAL !!!
Holiday. FDA doesn't continue negotiating with an
un-cooperative Sponsor. Waxman helped get the Rescinded
SPA back on the table, incorrectly assuming that AMRN
would help them reach a win/win compromise. Thero didn't
have a clue as to how to talk with The Agency. On the
Tuesday, prior to market opening, FDA pulled the plug.
Continued: AMRN and FDA had been negotiating for three
days. All FDA wanted was a compromise. Thero, with no
prior history with FDA, thought he could play hardball
and resume talks on the Tuesday following the
drrc: Let it suffice to say that if I could reveal my
source, I would. I would only add that it is an unimpeachable
source. FDA has a short attention span. If you recall, the
Friday before the MLK Holiday Monday, AMRN and FDA
JL: The bottom line to FDA's action was predicated on the
AHA/ACC Guidelines which did not include Trgs as a Non Lipid
Lowering Agent. LDL was the only non Lipid Lowering Agent that
was mentioned in the new Guidelines, and FDA knew about this before the ADCOM and behaved shamefully by high jacking the panel and rejecting Anchor. BTW, how are you ?
Williams: I'm not talking about Omthera, I agree on that point.
That said, their total strategy is essentially trying to salvage
the Co. through litigation, ie, 1st Amendment, NCE, and suing the
FDA over Anchor. After over 20 years in this Sector, including 10 years consulting for FDA, I can't think of one Co. that prevailed at the end of the day, by going into hand to hand combat against FDA. I have great respect for you and your work, but let's agree to disagree. This could have been all been avoided if Thero would have
compromised with Agency when the SPA was put back on the table.
That was all FDA wanted, saving face and revising the SPA. It would
have allowed AMRN to basically still market Vascepa for Mixed Dyslipidemia, with the tacit agreement to acknowledge, that there
was no data as yet to prove that lowering Trgs improved Patient Outcomes, and make the SPA contingent on Reduce-IT RESULTS. That
would have been a win/win for both AMRN and FDA. Thero played hardball, and by refusing to compromise, FDA was rightly angered and
pulled the plug again by rescinding the SPA a second time. A basic dictum in Biotech is you don't fuck with the FDA.
Confused & Concerned: Took some time off this site and
got a bit confused when I just logged in, read some posts and
thought I was on a Law School web site. What ever happened
to our miracle drug ? After 20 years in Biotech I can't
recall a new drug launched just 18 months months ago being
attacked by Spec Pharma lining up to come out with a generic
version of Vascepa. You've got to worry about the robust nature
of our Patent Estate, as this is pretty close to a first in the
sector. My concern is related miss guided approach of AMRN in
taking on all this litigation. My take is this is a sure sign
of weakness, and a wrongheaded, flawed, strategy. Without a real
CEO and Management team, it appears to me that the lawyers are
running the Asylum.
PCSK9:. There have been infrequent reports of (reversible) neurocognitive changes with all statins and language to that effect is included in their labels. Results of studies to specifically investigate these neurocognitive changes (ie studies with neurocognition as their primary endpoint) have been not determined a clear relationship. Comments made by FDA officials reflect these findings. As for potential mechanisms for effects on the brain, proposed mechanisms relate statins' inhibition of cholesterol synthesis. However, that mechanisms have been proposed does not signify that a link necessarily exists in our opinion.
Ironic:
Isn't this over the top !!!! I wonder why it took so long for people to figure it out!!!
1-800-382-5968.
Check your phone pad. 1-800 Fuck You is actually the number for Obama's Health Care Hotline 1-800-382-5968.
As you dial, look at the corresponding alphabet for each number.
This number was actually set up by Sebelius' Office at The Dept of Health and Human Services.
JL: Jesse, we are not in disagreement. If the bottom line is the anti inflammatory action of V, and not Trg reduction, then the endpoint of Anchor, Trg reduction in patients on statins with mixed
dyslipidemia, was according to AHA/ACC guidelines, not an accepted metric. As Vascepa was not considered a non statin lipid lowering agent in the guidelines and LDL was. It bespeaks why PFE,AMGN.SNY,
ISIS,and REGN's, drugs which lower LDL, will be approved years prior to the PH IV Outcomes Data. My guess is that's the reason Anchor
was really turned down. That and Mgmt stupidity for not coming on
strong on the anti inflammatory action of Vascepa during Adcom. Unless I'm missing something, we're both saying the same thing, with the disclaimer that you don't agree as to the reason Vascepa was voted down. I strongly suggest that complying with the guidelines was what did us in.
JL: I completely concur with your assessment. One caveat is
the Jupiter Trial was done by AZN and not as an FDA sponsored trial.
Their 3 prior outcomes studies all failed to show a reduction
in CVE's. The Street believes Jupiter enrollment was cherry picked
and all the data were mined in house. FDA Biostatistical analysis
was never done. I do agree on the anti inflammatory effects of V
should be the key determinant. That said, V was statistically significant in lowering CRP, and I don't recall Jupiter showing
that metric. Do you ? The bottom line of your erudite explanation does affirm FDA's Anchor decision. Thanks for your reply.
sts66: Only the Shadow Knows. With Mgmt's sloppy handling
of every other aspect of importance, my guy in Vegas has
the odds at 6 to 5 against.
JL: My biggest concern with Reduce-it is the ignorant decisions
Mgmt made in the trial design. Apparently Mgmt never thought
that they would not be bought out after the Marine approval 7-26-12.
Because of that they accepted FDA's definition of elevated Trgs
as >150 mg/dl. Thus putting additional hurdles in their path by
by enrolling the first 2000 patient's with Trgs around 150-160.
They finally realized another of their dumb decisions, and had
the protocol changed with FDA approval to define elevated Trgs
at above 200 mg/dl. Question, is the study still powered adequately
with 25% of patients enrolled with relatively normal Trgs ? One
potential effect will be a delayed event date, probably out to
mid 2018, and greater concern for their hitting the Primary endpoint.
BioBill: They need a deep pockets Activist to buy 10%
of the Co stock on the open market, get on the BOD, then
fire Mgmt, hire a real CEO with a proven track record in
our Sector . He should have prior CEO experience, respected
by both the Investment Community, and FDA, he should then
with the help of the Activist, fire the BOD and hire Industry
and Investment Community Savvy Independent Directors. That
will completely deodorize the stigma of failed Mgmt for
the past 3+ years.
yowyow: With the worst Mgmt in the Biotech Universe
the Geniuses have done an amazing job. However, they
nor anyone else is capable of executing with non
existent leadership. Great drug, the worst Mgmt.
Remember, Vascepa is 50% of the equation, ans Mgmt
is the other half. So far AMRN is only 1/2 a real
Company.
Nuts: Your comments about JL's post are convincing that
once again, you're wrong. This Dude knows more about Lipidology
than any well informed person at FDA, AHA, and ACC.
With $210M it is highly doable. I've actually been involved
in a similar situation and snatched victory from the jaws of
defeat.
Strategy going forward: The Rx for Success.
1-Engage an Equity Firm or IB
2-Have consultant list all share holders, try to get voting
majority of outstanding shares.
3-Have shareholder election, with slate of Directors, (Industry Professionals, Wall Street Managers etc.)
4-Place a new BOD, fire inept Management.
5-Hire a real CEO with an Industry Track Record, having served as
a CEO of a Publicly Traded Biotech Co.who has a history of successfully launching,commercializing and monetizing a new product.
6-Outlicense the Dialysis Indication to large partner, (Davita, Fresenius, for Diabetics on Dialysis for ESRD (with high Trgs and low HDL. Get upfront licensing fee plus milestones and profit share.
This patient population will have better outcomes, and fewer CVE's
7-Keep Reduce-it going
8-Patience and secure proper valuation for a great asset.
sts66: What's happening my friend is that at the highest levels
ie, Sebelius, Sec of Health and Human Services, marching orders
have been given . The survival of "Obamanation" depends on keeping
drug costs down. It doesn't hurt $50+B Genzyme , but destroys
a small biotech like AMRN. Shame everybody voted for the wrong
guy.
concapk: Simple solution: If we all put him on Ignore, and
no one responds, His egocentric personality will drive him
nuts. Though for the most part I suspect he likes talking
to himself, lets give him that opportunity. Y'all simply
give him the "Iggy"
BioBill: The FDA's CSO, Jesse Goodman was the fall guy picked by
Margaret Hamburg to fall on his sword. Reason being, the heat
brought to bear by both Houses, for the Pseudo Science used
by FDA to vote down the Anchor Indication. Apparently a Bipartisan
group of Congressmen and Senators told Hamburg that FDA should be
held to the most rigorous "Highest Scientific Standard".