"Substantially underway" doesn't have to do with patient enrollment. It has to do with actual progress of the study. When someone is organizing a marathon race, do you consider it substantially underway when everybody has signed up for the race? What about when they are all lined up at the starting line?
Would you say the marathon race of 26.2 miles is substantially underway when the gun goes off?
This is why we shouldn't start throwing a party.
The FDA could easily define "substantially underway" any way they want. There is plenty of room for them to make it mean whatever they want.
Also, Amarin posted their "belief" that the government won't shutdown and THAT is why adcom and pudufa will not be affected. That is great, and I agree that odds are leaning that way, but the republic far right really want the shutdown this time. If the government shutdown does happen, it could push adcom and pudufa into next year and the market in general will freak out and that will cause a crash beyond our own AMRN stock issues.
My biggest fear is that the FDA will want actual proof that lowering lipid count actually translates into reduced cardiovascular events before expanding label. Reduce-it is hopefully going to prove that, but the proof is till not coming until 2016. Prescriptions have been so small that we will have some radical moves needed to make it much longer on such small income.
People keep mentioning percentage increase, but that is expected with a new launch. Anybody who knows statistics and percentages understands the numbers and why they shouldn't be all that excited about the prescription count thus far. Look at the INCOME coming in from those prescriptions.
Check out prescription count for ALL new launches. The LAUNCH is always very similar, it is the later increases where the differences are established.
Anyway, there are plenty of good stocks out there, don't lose it all here gambling on ifs and buts and wishes and beliefs.
Tip: good issues that I have mentioned in the past on the board. Enrollment has reached 6000 but they are all cycling at different timepoints---they all don;t start at the same time. Its why I own 30% of the shares for this meeting versus what I would have bought if there was no meeting. Because I know that ANCHOR data is so good, the meeting, if its going to just be about ANCHOR, wouldn't be necessary!
I would have even bought more shares than current without a panel meeting, and it pwould help if this trial currently enrolled at 6000 on had a fallback postion for AMRN and that would be an interim analysis worked into it. Then any delay over whatever would be shorter. But it appears there is not.
Therefore I see three potential outcomes:
(1) they accept ANCHOR as one P3 study on its own merits and approve for this population. Many believe this--it could happen?
(2) the meeting means we should see some arguing over whether approving this indication off one P3 studyis warrented. Its clear that the current running study is placebo-controlled, blinded and a P3. Its not a mirror of ANCHOR but similar and usually for a patient populations this large, the agency wants 2 P3 trials as support. In MARINE they used MARINE and ANCHOR. An interim analysis point on the ongoing study would have been a moderate delay if required until enrollment cycling hit a certain point and less of a wait if delayed via the upcoming meeting.
(3) they want the total results of the ongoing study before moving to consider approval---then we are talking 2016 and AMRN is totally stuck. Then it would be clear the FDA CONNED AMRN.
I don;t know the percentage chances of all this or which one is most likely to occur, but its clear any of the three are possibilities! I will play here, but I aint going all in---I know the FDA and their antics just too well----would rather chase for more shares if #1 occurs than risk #2 or #3 happening.
Each has to decide the odds here!
I don't totally understand your position and somewhat sanguine attitude. The Anchor indication is all about safety and efficacy of Vascepa when combined with a statin - period. People are attempting to tie Reduce It but it does not fit into the parameters of the October 20 meeting. If you don't believe me, do a little research on the Anchor sNDA application.
Kutz, you can talk circles around anybody. Your distinguished pessimism is acknowledged. Just one question. Out of all the failed ADCOMM's you've seen, did any come close to Vascepa's safety profile?
Sentiment: Strong Buy
Oh they are being treated per the protocol, but its not a marathon because they start at different times and thus finish at different times in this study! its obvious that AMRN is not having problems enrolling, its just a long study to wait for final total results!