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.