What "evidence" do we have, if any, that the FDA WILL reach a final decision on NCE status in October? In short, it seems that most everyone expected a decision in mid-August, then a few weeks before that date guidance was provided about a possible delay given ongoing discussions. No definitive statements were then made, but seemed that many were expecting a decision in mid-Sept. Now that there has been another delay, what evidence, if any, do we have that a final resolution is coming mid-October? And, if we don't receive a decision in October, how long might it be until a final decision is made?
Serious replies only please.
i think amarin's lawyers were well prepared to defend NCE status for VASCEPA and they must have presented that information as basis for Amarin's case.
Remember 889 patents which was originally not approved,but Amarin's attorneys met with Examiner's supervisor and presented their evidence.AND now 889 has been approved by the same examiner.
This examiner has approved 4 other patents also in one week.
So my guess-Amarin must have hired TOP Lawyers--who know HOW TO DEFEND NCE?
What that evidence is --did it include patents like 885--is unknown to me,but it is a STRONG evidence document.
That is why MKM analyst LeRoy has made positive statements about NCE.He is in touch with Invest.Relations Shultz and of course consulted some lawyer. These analysts give advice to INSTITUTIONAL investors.
Sentiment: Strong Buy
Sorry, but no. The FDA does not work like that. You do not get to "defend NCE". Amarin may have presented their arguments (more likely, the patent stuff) *ONCE* in the FDA OB meeting, but beyond that they do not have a voice and the FDA will not talk to them or their lawyers, so I am afraid your post is a billion miles off the mark. Sorry to rain on your parade.
fda may be waiting for patents for 885 or something else--to be sure ,although nce does not depend upon on patents. 885 patent is a key patent.
there seems to be some system problem at us pto -it should have been issued 10 days ago.
885 sent to FDC on 9/19 after an apparent mix up when sent on 9/07. Someone mentioned earlier that AMRN was told of the descrepancy and this may have been what keyed them in that the OB exclusivity may be delayed. We should have our patent on 885 w/i 4 weeks if not sooner. This would put us around the middle of October so will be close if we get it before Oct OB. Just my thoughts.
My guess in two weeks on Oct 14.
Ceo is not foolish to go it alone since it will be huge task to market which is easier to do under big pharma so the best option for amarin would be to sell the conpany to highest bidder. My strong guess is bids are already on table since big pharma is very hungry and who would like to leave the next lipitor on the table?
Finally my doctor and other local doctors group think fda should grant nce but again it is fda who has to make up their mind. Now that they had full 3 months i expect a yes or no by Oct 14
My guess buyout price with or without nce
25 without nce 3 years exclusivity
45 with nce 5 years exclusivity
As you can see above that is a big difference in final buyout price hence it makes sense for big pharma and amarin to wait for nce decision before finalizing the deal. My sixth sense tells me Amarin is in very late stages of buyout talks. Recent CT FILINGS and UBS cancellation add spice to sugar.
All these are pure guess only.
There will be "possible" update of OB & NCE status in october.
The fact is the CEO mentioned for october there will be the decision about the going-alone option....
Everything else is speculation.
But IMO, also the above CEO's statement was speculation to excite the players (buyers/partners).
Yes, it seems we're still completely in speculation phase. It doesn't seem that there is an easily discernible date or event that marks when a final decision would be made. I'm not sure what to make of AMRN management; clearly, their PR efforts seem to leave a lot to be desired.
This is my expectation: We go alone, NCE status granted on Nov/Dec after more patents are issued and not just allowed. Price will be around $10, but will rise to $20 mid 2013 when sNDA for ANCHOR is decided.
So why do i hold at these levels when i can just buy later? There is that homerun potential, and that is the only reason im holding now. But my honest expectation is we go alone and NCE will get issued by Dec.
I am willing to add end of the year, if we are around $8, which i doubt.