Since Vascepa has not launched commercially yet, if AMRN eventually gets NCE status, these month by month delays we have been experiencing from FDA undecisiveness is actually good for Amarin. This is because we are not losing precious months of exclusivity on the months where Vascepa is not even being sold.
So if NCE was granted in August 2012, we would have already wasted 4 months of exclusivity (assuming Patents are worthless which they are not).
Think about the bright side. These FDA nce delays are good for AMRN shareholders IF we eventually get NCE one day!
Sentiment: Strong Buy
With the delays, and AMRN accumulating patents, the FDA decsison to deny NCE becomes more and more difficult. AMRN's case gets stronger month to month. The FDA has had ample opportunity to deny, but they clearly are keeping the door open on approval because thet see what's developing on the patent front. Besides, as was already mentioned on this board, maybe if they keep kicking this decision down the road for a few years, AMRN will have de facto NCE!!
Pasted from the Code Of Federal Regulations: "Date of approval means the date on the letter from FDA stating that the new drug application is approved, whether or not final printed labeling or other materials must yet be submitted as long as approval of such labeling or materials is not expressly required. “Date of approval” refers only to a final approval and not to a tentative approval that may become effective at a later date
From the FDA: " Five year data exclusivity from the date of first NDA approval for products containing chemical entities never previously approved by FDA.
The above should answer your questions as well as tell which of the above posts are so wrong. The clock is already running. The question remains how long the clock has going forward-3 years or 5 years. If for example the FDA where to decide in July '13 that only NME then the clock would have 2 years left (July '12 approved minus 1year). If the FDA were to decide to give NCE then 5 years from July '12. And in an extreme example, if the FDA decided July '16 (4 years from approval) only NME, Amarin would have the benefit of an extra year.
isn't it NCE starts from the day of approval? if you think of opposite, if the launch is not as successful as planned and if NCE is denied, let's say next march or april, then it'll be completely the other way..since their ultimate goal is to sell the company in the near future, it's better to sell it now in between NO NCE and YES NCE ..
you say this is a good thing because you think FDA date of exclusivity starts on the day that FDA gives the award? Why don't you think it starts from the day the NDA was approved, and then all these months have been wasted, if exclusivity really matters.
Please don't mislead people. Exclusive count from Approval and not date it announce. NCE decision is much better as it would allow company board to evalute company current value and we might have good deal in place by now either BO or partnership. Although this might turn out good deal only if launch is unexpectedly successful. It's hard to tell how good sell team will be and how doctor will respond and so launching clear those detail.
But very successful launch is very hard if we go by recent drug launch history. Good thing is price already mostly accounted for bad launch and so if slightly better than other drugs launch could start relly.
To justify current price point (Around $12 at end of next year). , company only need to sale First year sale of about 70M which is not much hard.
Sentiment: Strong Buy