Selling all stocks and taking a break.

Sold all AMRN @ 1.80

Sold all VRNG @ 3.22

AMRN’s management has managed to do absolutely nothing.  They are the definition of incompetence.  

After ANCHOR SPA was rescinded, they appealed, and that appeal got rejected.  AMRN has been nothing short of absolute failure.

With AMRN, for the first time in history, the contract w/ FDA was broken (this is first time in history folks.

Is the FDA corrupt?  of course they are, but not this blatantly.  That said, i truly feel AMRN should currently be in the 5s with the current approved indication, but thanks to the unbelievable drama, it is at 1.80.

ANCHOR will get rejected on Dec 20th and I’m pretty sure we can buy this back lower if that happens.  That said, we can be bought at at triple these prices, but i need a break.  I lost more money than what some people make in their lifetimes on AMRN stock alone, and yet I will learn from the mistakes and move on and become a better investor.  

Good luck to all!

Posted in Uncategorized | Leave a comment

Briefing Document notes

Good evening everyone,

Briefing document from the FDA was released on Friday and talk about a wild ride.  Stock went from $6 to $7 and back down to $5.

On this Wednesday, there will be a all day FDA panel meeting to vote for approval of ANCHOR indication.  While i was hoping we would be higher than we are, obviously, we are not.  That has to do with the negative tone taken by the FDA briefing document.  As i have noted in the past, most of the briefing documents are negative in nature to induce discussion among the panel members.  

We held this long and i plan to ride this out for the vote.  Although there were many instances we could of sold for nice profit, we didn’t.  I believe there is a good chance for good votes.  There will be AMRN conference call on Wednesday 4PM to discuss the results.

Monday and Tuesday will probably be wild swings and I have no idea where it is going, but it really won’t matter until after the votes.  The drug is very good but the question for the vote is whether we wait for the current REDUCE-IT trial or approve it before the result of REDUCE-IT outcome study.  Lets cross our fingers and hope for the best.

Posted in Uncategorized | 2 Comments

AMRN schedule

I had a strong expectation we would go up by FDA panel meeting and surely enough, it is going up very nicely last two days.  Lets hope it keeps going up.

9/6 – Weekly Prescription data.  Also my birthday :-)

9/13 – Orange Book Update.  Possible NCE decision for Vascepa.  Another Weekly Prescription data.  This data will not be as good since we had a holiday.

9/20, 9/27, 10/4, 10/11  - Weekly Prescription data.  These are important.  As long as they grow, stock price should go up.  We are at 5300s right now.  Im hoping for 5600s tomorrow.  Once we reach 20,000+ scripts, we should break even.  I expect to get there by end of next year.

10/14 – FDA briefing documents for the panel meeting.

10/16 – FDA panel meeting to vote for the 200 to 500 indication.  Stock will probably not trade this date.

10/18 – Orange book update, if NCE is still in play.

I will decide whether to sell all, half, or keep around first week of October.  Of course, you guys are free to do whatever you guys want.  I’m known to be wrong approximately 50% of the time :-)

 

Posted in Uncategorized | 3 Comments

FDA panel meeting Q and A

Q:  What is FDA panel meeting?

A:  When a company applies for a drug to be approved, FDA calls for a panel meeting to get outside help to decide whether the drug should be approved or not.  At the end of the meeting, FDA asks the panel member to vote either yes or no.  If it passes, FDA usually follows the vote.  I have seen opposite happen, but it is more common that FDA follows the votes.  FDA will make its decision sometimes in Dec of 2013.

Q:  Isn’t AMRN’s Vascepa already approved last year?

A:  Yes it was, but they were approved for lowering Triglycerides for those who have more than 500 gm/dL in your blood.  Amarin corporation is trying to get Vascepa to be approved for those with 200 gm/dL to 500 gm/dL (name of this indication is called ANCHOR).  This indication is 10 times more population than the 500+ gm/dL population (Marine indication).  I currently take a competitor drug since my levels are high.  Will switch to Vascepa on my next visit to the doc.

Q:  How is the sale for Vascepa doing right now?

A:  Vascepa launched in Feb of this year with 275 salesman.  Currently as of last week, there are little over 5000 prescriptions written every week.  1st Quarter they did 2m.  In 2nd Q, they did 5.5m.  In 3rd Q, they’ll probably do 12m, and 4th Q, 25,.  At this rate it won’t take long to get this stock running imo.  Analysts are expecting over 200m for full 2014.  If we do that kind of sale, stock should be easily double to triple.  Big if, but we will see.  Oh, I’m not even counting on the new indication (ANCHOR).

Q:  What is this briefing document you mentioned?

A:  Briefing document is a long (couple hundred pages) document FDA gives out to the panel members couple of days before the meeting to summarize what the meeting will be about.   It will contain all of the clinical data of the drug in question along with FDA’s opinion regarding the drug.  It usually is given out two days before the meeting, but i have seen it anywhere from 3 days to 1 day.  Soon as the briefing documents are released at the FDA sites, stocks react violently.  In ARNA’s case, it shot up.  In other cases i have seen, it shot down.  Usually, it goes down since FDA mentions all of the risk associated with the drugs.  I have personally read probably 50+ briefing documents in my life time and ARNA was the best I have ever read.  Obviously, that was approved and made us lots of $$$$$.

Q:  Why are you in 40 percent of your portfolio?  I though you said you should be diversified and not gamble.

A:   Simply, I’m pissed VICL didn’t work out and need my money back.  J/K.  Seriously, AMRN prices is currently around $1.1 billion market cap (company worth).  The competitor (Lovaza) sells around 1.2 billion dollars worth every year.  And that drug is worse than Amarin’s Vascepa.  Eventually AMRN will sell a lot, especially if they get approved for the new indication by end of the year.  No drug is approved for the 200 to 500 population.  If this gets approval for it, i can see this going to $50 easily, in couple of years..  If it doesn’t get it, they will still sell the same drug and eventually do 500m in couple of years and still goto $30.  Bottom line, if NO vote comes out, I think we’ll go down to $5 at the worst.  If yes vote, I think we’ll goto mid teens and probably get bought out by the BIG Pharmas like Pfizer or Johnson and Johnson, or GSK (competitor).

Q:  What do you personally think will happen on the panel meeting?

A:  All of the analysts covering AMRN think it will pass.  AMRN has SPA (Special Protocol Assessment) with the FDA.  That is a contract saying if you do certain trial that FDA asks and it passes the trial, FDA will approve it.  Well, AMRN did the trial and passed it, so they should get the okay, but there is another trial that FDA asked to do and that has not been finished.  That trial will finish sometimes in 2016 and that is why i personally think FDA will wait for the trial to be finished.  Depending on the price when we approach the event, i will probably sell all if prices is $8 or above, or sell half if anywhere between $5s to $6s.

Good luck everyone, it will be fun, unlike VICL, we know exactly when this will play out and thus get out with profits or risk only small amount.  Remember that AMRN already has the same drug on the markets and even a NO vote will drop it only slightly in my opinion.  Long term, i think this company will be a HUGE winner.

Posted in Uncategorized | 2 Comments

Add AMRN 20 percent at 6.30.

Call me crazy.  Market is tanking and I’m adding AMRN above where I bought it.

Oct 16th is the FDA Panel meeting and there will be volatility going into it.

I expect this to be around $8 by the date.  The ANCHOR indication will be huge for their FDA approved drug, VASCEPA.

Their weekly prescription has been steadily going up and it bolds well for the stock price.

My Plan:  Will make decision by first week of October and mostly likely exit everything if i have good profits.  If we are still around $6 to $7, will sell half and wait for briefing document to come out and decide what to do after reading the briefing document.

You must sell by Oct 10th to risk not seeing briefing documents.  I expect the FDA briefing document to come out by Monday Oct 14th, but I have seen it come out earlier.  Stocks usually go up or down by 10 to 20 percent when briefing documents come out.

Good luck everyone.

Posted in Uncategorized | 2 Comments

Buy AMRN $6.03, 20%. Buy VRNG $3.39, 10%

Lets start making money again.

AMRN will have FDA panel meeting on VASCEPA, already approved drug for wider indication.  Date:  10/16/2013.  Meeting notes will be out 2 to 3 days before this date.

VRNG:  Court battle w/ google, aol, msft, etc.  will spike one of these days and will sell on the spike.

Will add others soon for mid/ long term.

Posted in Uncategorized | 4 Comments

Taking a little break

Hi guys.  After a big play, it is a good idea to relax and enjoy the air.  

Market has been declining and I am all cash 100%.

I am watching these currently.

AMRN.  They have European meeting as well as new indication from FDA in a couple of month.  However, with the markets kinda in a selling mood, perhaps waiting a week or so before doing anything.

THLD.  Long term, makers of pancreatic cancer drug, who has a phase 3 trial.  Will be 1 year away, but always nice to buy ahead of the crowd.

MNKD.  Insulin drug that just passed phase 3 trial.

ATRS.  This brought to us by one of my hyungs.  Has a FDA decision late this year and can possible double.  I might buy this for the ride up to the FDA.

Stay safe and CASH for now.  Will start to dabble here and there to make up for VICL.  Carefully and slowly.

Posted in Uncategorized | 1 Comment