My question: Can Amarin sue FDA for changing their mind on Reduce-It study?
This will be a way to show:
1) Vascepa acts differently than Lovaza or other Fish oils.
All lower Trigylcerides,but Vascepa lowers C-RP by 21%--not shown for Lovaza.We know Lovaza raises LDL-C by 45-49%.
2) Bring in Japanese experts who have analyzed JELIS data--to show EPADEL works by lowering Inflammation--Japanese use AA/EPA ratio--where as Amarin measured C-RP
3) The whole advantage of Vascepa-like Epadel in Japan is reduced CV events thru inflammation reduction which was proved statiscally in 2011 article in Atheroscl.journal.
4) Hire Dr.Barry Sears to testify--he is an expert on Fish oil and Inflammation.He sent me 2011 article long time ago.
Dr.Yokoyama said in 2008 that EPADEL benefits were due to reduced inflammation.Recently in 2011 and 2013--they used AAA/EPA or EPA/AA ratio to show the reduction in CV events.
Experts: Can Amarin rewrite the FDA application to add reasoning that Inflammation reduction--Anchor study measured C-RP reduction.
Makes sense. The only option is:
1) As Matt Herper of Forbes emailed me-- Continue Reduce-It-as this gives doctors confidence-that Vascepa/Amarin is spending money to verify its benefits.
2) Cut back elsewhere to the bones for 2-3 years to survive. Here only keep essential top management-pay them some salary-but more thru stock options.If they decline--then that means -they have NO CONVICTION--would you have some one leading who does not have conviction ?
3) Pharmacyclic Inc.-PCYC went from 80$/sh. in 2000 to 0.75$/sh. in 2008 .No one would lend it money. Robert Duggan was hired-replaced Richard Miller-Chairman,CEO-- Duggan lent 6.4 mil.$ and later bought 20% of the outstanding stock--later found partners --Johnson & Johnson who gave lot of money(Milestone payments) for 50% of profits. PCYC is now close to 124$/sh.
By the way at Reliant,Joe Z. left in July,2007-Paul Huff stayed on and left after GSK acquisition in Nov.2007. So it seems that Paul Huff was kept by the founder-but not Joe Z.-MUST BE A REASON.
Was not aware of Paul Huff departure. In current lineup-- among top managers--who is most competent to run the co.,if cash becomes a serious hurdle and mgmt. does not accept large pay cuts for 2 yrs. until Reduce-It study results are partially available.
Who among Directors is most competent to run the co. if Joe Z. is not there?
KM--you were right about your judgement on Scripts and NCE.
156 million shares were traded on 17th,18th and 21st Oct.,2013. Total shares out are 170 million$.
SEC knows about it.Who bought is not available yet-but will be in 3 months.
Anyone buying more than 5% of aco. is legally required to report it to SEC.They have to disclose their intentions also.
Ichan has bought more than 5% like Warren Buffet. They all disclose their intentions to SEC.
Richard Miller ,CEO of Pharmacyclic wrote an OP ED in Wall Street journal about FDA. FDA had rejected one of their drug for brain cancer.This aricle was published in 2007-after Miller got frustrated with FDA.
Pharmacyclic Inc.-PCYC-- stock price was 79.81$/sh. in Feb.1,2000,it dropped to 0.7%$/sh. in March 2008.Today it is 125.67$/sh.
PCYC former chairman got so mad with FDA that he wrote an OP ED in NY Times or Wall Street Journal.
Anyhow,the board of director found Robert Duggan -now 69 to join in Sept.2007.The previous CEO resigned in 2008 and Duggan became Chairman in Sept.2008 after previous CEO resignation.
PCYC was in trouble-no one wanted to lend money. Duggan lent 6.4 mil.$ to PCYC and also bought 20% of outstanding stock over the next couple of years.
His Salary in 2013-- ZERO
COO salary in 2013-- 266,000$/yr.--Dr.Mahkan Zanganch-called Maky worked for Duggan before.
Later they were able to sign a big deal with Johnson & Johnson to get money for R&D etc. for 50% of the drug sales. PCYC survives on Milestone payments and now has been able to raise money thru loans etc.
AMARIN's officers should follow Duggan's example-if they truly believe in VASCEPA.
Another writer suggested the top officers take a cut in salary-perhaps accept $ 1 /yr. salary .
CEO of PCYC-Pharmacyclic did that .He even lent 5 million$ when no one wanted to lend money to PCYC. He had a big fight with FDA also-even wrote an OP-ED in NY Times or Wall Street journal 4/5 yrs.ago.
Finally Jennsen-Johnson & Johnson signed a deal for 50% of Sales--and lent money as MILE STONE payments.
PCYC which was selling for pennies after FDA debacle-- is selling for 125$/share.Check out the story yourself.
PCYC salaries were very small for 2-3 years until JNJ deal.
Top officers have earned a lot in 2011,2012 and 2013. They should all chip in 50 mil.$ to boost Amarin's cash position and accept $1 salary for 2 years.Like Pharmacyclic ,they will boost other investors confidence that Reduce-It study will produce good results and they are willing to risk their money and time for 2 years.
By the end of 2015,we should have enough data to know the likely outcome.
However,this move by top officers-will put a floor on stock price.
If some officers are NOT willing to join in--they should be allowed to leave the co.
Agree. CEO of Pharmacyclics Inc. found PCYC in tough situation after problem with FDA.
No one wanted to lend money-stock was selling for pennies.
The CEO lent 5 million$ of his own money.
The top officers have earned a lot in 2011,2012 and 2013. If they are convinced that they can turn this co. around-let them put up 50 million$ of their own money and accept $1 salary for 2 years.
That's what Joe Z. said in July,2011 when stock was around 19$/share to Bloomberg reporter.Check out that news report.
Later Joe Z.said that Vascepa will walk over Lovaza.Look at Vascepa sales with so called"top Salespersons ".
Joe Z. has tried his best--but FDA did not buy it, doctors are NOT switching fast enough,and S.G.A has swelled up in 2013.
Reduce-It study results offer a hope --if successful,then those patents are worth a lot.Hopefully ,then the doctors should be able to use Vascepa more and FDA may grant Anchor approval.
But that's possible if Cash is used very carefully until 2017 as getting money will be tough without losing independence.
Remember the clause in loan--Patents were collateral.
The only way to survive till 2017 is to "CUT BACK TO THE BONE.--while spending 55 mil.$ in 2014 and 2015 on Reduce-It. Hopefully ,the data at the end of 2015 should give better indication.
If this type of tough actions are implemented by John Thero at the urging of Board of directors ,AMRN can survive and remain independent.
There is NO need of executives earning 1 mil.$ or 250,000$-- Amarin has to be run now as a very tight ship--with no more lecturing to investment bankers.They don't need a CEO,President ,CFO and all other VP. That strategy has FAILED. All you need is one of them to run the co.with managers earning close to 100-150K $ salaries with some bonus in the form of stocks.
All the genious marketing or legal or technology VP--performance has earned grade of D or F in 2013.
The Board of Directors don't need more time.They must act fast.
Motley fool has an interesting scenario for GSK - what they can do to lower S.G.A.
Here is my take on that. It will be nice if GSK were do that.But why can't AMRN CEO or Board of Directors do that themselves.Why do they need GSK to act.
My plea to the Board of Directors.
1) Joe Z. will take long time to act--as he hired the top management himself. Firing 150 sales person was an easy decision.Their performance was measureable and lousy. Why did Joe Z. wait that long?
2) For Marine indications--with Lovaza going generic-with bad publicity--sales growth will be tougher.
Matt Herper of Forbes wrote to me: Reduce-It study continuation is absolutely a must for Amarin for commercial reasons-not only Science.If it is discontinued-doctors will be disappointed(not patients). The current market cap is due to Reduce-It study proving that Vascepa should reduce CV events significantly.Without that he opined that AMRN is not worth 2$/share.
3) given that Reduce-It study may cost 35 mil$ in 2014 and 20 mil.$ in 2015, other areas must be cutback to keep AMRN solvent. Motley Fool offers some thoughts.
a) Joe Z. and others at top should either offer resignation or accept 75% cut in their salaries.If that doesn't happen soon,the Board should fire CEO and appoint John Thero to do the reductions in top management who are also responsible for poor performance of Vascepa Sales so far,not resolving NCE issue or unable to convince FDA for Anchor.They all had hints all along-but they stuck with stuburn attitude.Well now their talent is NOT needed and they must leave. S.G.A as a % of sales should be closer to Motley Fools % of 35% in 2014..If GM is 70%--S.G.A is 35-40%,then gross profits can be 30% .Yes--interest payment for loan may reduce that to 20-25%.
b) 25% gross profit on sales of 70 mil.$ in 2014 means 17.5 million$. Reduce-It expenses should be held closer to 30mil.$--but assuming 35 mil.$--Amrn loses 17.5 mil.$ in 2014
Good information.Dr.Topol wrote an Op-Ed- in NY times over a year ago,pointing out that Statins lower CVD events by 2%,but creating Diabeties in 1% of patients taking Statins.
Cardiologists are worried about side effects of Statins. I got type 2 diabeties from Lipitor which I took in high dose since 1997.So for last 5 yrs. I have lowered my dosage to 20mg./day with doctor's consultation.As my trigylcerides remained high( around 250-350 mg./dl.),inspite of taking Lipitor in 40mg./day strength.
I am anxiously awaiting FDA approval of Anchor indication.
I saw the study about Epa helping reduce inflammation in 2011 journal sent to me by Dr.Barry Sears of ZONE DIET. This study used JELIS data and showed EPA/AA reduction from 1.6 to 0.8 for those on EPADEL -96% EPA .He believes EPA/AA ratio is very high for Americans compared to Japanese as our average is close to 4.0--higher than 3.0 considered OK.
The other part that you mention -pl.give us the title,year/date etc.-so we can read it.
Look at JELIS study--after 1.5 yr.results started to diverge for Epadel-96% EPA vs.Placebo.
Americans suffer more than Japanese for Heart disease.