Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Repatha got priority review despite much lower RRR and no death benefit.
Cant see sNDA for Vascepa not getting priority review given Reduce IT RRR
and when EVAPORATE shows that Vascepa is literally a liquid stent, he will look pretty bad.
9.3 pct weekly nrx growth, annualized is 10,192 percent annualized.
Just saying!!!!
Any buyout could be small potatoes versus licensing agreements with MULTIPLE big pharmas at the same time... :
Given that Vascepa is to be prescribed on top of statin therapy, combo pills will emerge at some point.
I find it an intriguing and potentially most accretive strategy for AMRN to manufacture combo pills with Crestor, Lipitor etc and then comarket the combos alongside the large pharma sales forces. Big pharma would get their beloved brands back from the generics and the AMRN salesforce would in essence be bigger than that of any single big pharma.
Or maybe license Vascepa to them and they create their own combo pills.
Or AMRN could be sold to a consortia of big pharma so that they could each go to market with their own combo pill.
Unique deals but Vascepa is a unique drug!
No, Citi UPGRADED in mid Nov w $28 price target.
Harvard v margined pajama day traders.
Which side do you want to be on?
Shooting spitballs at a battleship.
When the FUD dies down we go much higher.
Guess what, this drug worked down to 135 Trigs! Can you say even larger market!
how did your tell your wife...???
here is my story:
every morning i wake, at least briefly, at 415am to check my email as i work mostly east coast hours.
at a bleary 415am california time on monday 9/24, my alarm went off as usual and i rolled over and checked my phone. i saw an email near the top of my inbox from a financial news service that i subscribe to. i knew this email could very well be the results of the reduce it trial as all amrn prs come in the am ireland time or basically middle of the night california time.
i sat there for a second before clicking open the email, knowing that one of the biggest battles of my life, a defining chapter in how i relate to my past, present and future existences from here on out, was about to be finally determined.
perhaps it was because of how long a ride this has been, perhaps because the stock was acting like shit into the announcement due to some potential information leak, i was not expecting amazing results. but i never sold a share.
maybe i never sold because if there was to be pain coming, it wasnt going to be because i decided to sell at the bottom and concede defeat. the pain would have to be inflicted on me when it was ready; i had no intention of bringing pain on myself before that. but perhaps part of not selling came from my belief in a good result, against all odds in large cv outcomes studies.
when i decided to finally click open the email, it took me a second to make sure i did not read the words "did not meet primary endpoint" and only the words "met primary endpoint" were present on my phone's screen.
i took a few deep breaths and read further. p<.001. a deep breath. 25%RRR another deep breath. how could this news be real, in the dark, at 415am on a mobile phone screen just as the weekend was ending and a new week was starting?
i read the whole pr about three times and just kept thinking, oh my lord.
i felt like andy dufresne at the end of the classic movie the shawshank redemption.
i knew that one day, i would receive an email at 415am with reduce it results and that i would open it and then eventually i would have to let my wife know what happened to amrn.
that day had now come. when i had a chance to gather my thoughts, i hit the forward button on my email app and sent the reduce it headline to my wife (still asleep). in my reply was only one word:
Redemption.
generally poison pills are put in place when companies are having trouble and could be swooped up at a bargain price.
in this case, amrn is doing just fine and a poison pill would be counterproductive to a takeout...
or said another way, by the time exclusivity ends, vascepa should have such scale volume in terms of supply, it is unlikely that generics would be able to even compete on price. while v could lose market share due to new entrants, it seems less likely they would lose market share on price alone...
well, they could have dyed the mineral oil yellow, dont you think?
no going back from the 25% rrr at this point in reduce it, although it will be interesting to see data from control arm.
as a side not, active arm in Strength will know it, as the epanova causes greasy runny shits..
Corn oil in Epanova STRENGTH Trial.
I know that has probably been discussed in the past, but FDA also signed off on use of corn oil as placebo in Epanova outcomes study.
Why did they use corn oil and not mineral oil?
Redemption is better than revenge.
Congrats all. I have been away from the board for a few years now but I never exited the stock.
Now on to "Robust" secondary endpoint disclosure!
yb
likely the dmc will receive a few different snapshots in time, including the 967 and then additional events until data lock.
i believe this to be the case because if you recall, the company was very slow to finally get to full enrollment. clearly they did not want to risk a bolus of final enrollees at the very end and then get unlucky with a lot of rapid events in the V arm very soon after they were enrolled and before the drug theoretically began to work.
by very slowing finishing final enrollment they reduced this bolus risk while then taking their time to lock the database allowing a look at more than 967.
thus they get the best possible from both worlds...
gross margins already above 70pct last quarter. they could go higher with higher volume purchases of api. only scenario where prices would really rise would be tight supply of api, driving prices of all o3 products higher.
tnx gabor
i dont know if everyone here knows that endpoint assessment in jelis was blinded; i didnt. its another small positive for reduce it trial design...
comparisons to jelis are all very encouraging, especially lower risk in jelis control even though low statin and high ldl.
but the one risk in comparing to jelis - jelis was open label. perhaps that doesnt matter for death but do we really know how open label protocol could have affected event data?
When Medivation announced very positive results for its pivotal P3 in late stage prostate cancer the stock rose from about $8 to $16 (pre split). the stock shared some similarity w amrn as it had been a big dissapointment about three years prior. steadily wall street returned to mdvn and the stock eventually went to $120 pre split.
so, i think that it will take a while for amrn to fully rise on positive reduce it results.
Zu is on to what might be the most important single question that may not have been analyzed yet about interim.
How many mortality events will be required at different rrr levels to get to stat sig.
We know in jelis, mortality was reduced at what looked to be a stat sig level but in the end there just were not enough events for the reduction to be significant.
most likely just a large vwap trade as underwriters pull down the green shoe (overallotment)
If you look at the epanova package insert and trial results you will see they had like 8pct gastrointestinal side effect rate, and that was in a 90 day trial. Imagine what the GI side effect rate would be if you had to stay on the drug for a year.
How could they even do an outcomes trial when so many drug arm patients would either drop out or know they getting drug due to their increasingly greasy fish smelly shits and farts?
that was 99pct likely a vwap trade by an institution - volume weighted average price. basically you put in a buy order during the day to be slowly filled until the close of trading.
JL could not be more correct.
Placebo rate in REDUCE IT is ALL THAT MATTERS RIGHT NOW. If you dont understand why this is, ask the board politely and someone will reply.
ONCE AGAIN, PLACEBO RATE IN REDUCE IT IS REALLY ALL THAT MATTERS RIGHT NOW.
of course if dmc says stop they will do a crossover arm to get more data...
if dmc says stop that is what will happen. trial from that point on will be biased if not.
ask yourself: if you were in the trial and at risk and you heard that dmc recommended stop and you were not sure if u were on v or mineral oil, what would you do? you would drop from the trial and get drug....
Glad to see Merck engaged in T2D research...
dmc recommendation will be a material event. they will need to disclose it.
would be very difficult for amrn to continue study in double blind fashion if dmc recommends to stop and amrn wants to continue.
think about it this way:
if you were a patient in the trial and you didnt know if u were getting MO or V - and then you learned that DMC wants to stop for efficacy. would you want to take risk of getting MO for another year and having a heart attack?
they could continue open label with crossover of placebo patients to drug...
that wuold provide more data
while management has downplayed a positive interim result there is one clue which is undeniable indicating that management believes there is at least chance for a positive interim halt:
the fact that they didnt fully enroll the trial until they hit interim event threshold.
if you were mgt had thought there was no chance of positive interim, you would have fully enrolled reduce it earlier. that way you would get maxiumum curve separation by the end of the trial.
by waiting around to enroll these last patients until after interim threshold was hit management was avoiding being "unlucky" where some recently enrolled patients might be on vascepa for 1 week and have a heart attack. now that the interim threshhold has been hit even being unlucky w a few events probably even out over the next 1.5 years
we know that if there is a interim halt for overwhelming efficacy, it will likely be by a small margin. so every event is needed. if mgt thought there was no chance for interim, they would have enrolled the last patients faster, to get more curve separation over time. since they did not do this and didnt want to be unlucky, they think there is a decent chance for interim stop and were willing to give up a bit of trial power to play that card...
yb
tnx raf.
yes, but even at 21 months left till end of trial still results in blended rate of 5% so event rate trending higher which i suppose makes sense as patients age.
at 20 months event rate is 5.3pct...
some key thoughts on the moving parts to reduce it rrr and what we know so far
1) as of about march, reduce it crossed threshold of interim 967 events, though events not yet adjudicated
2) company still anticipates to complete all 1612 events by end of 2017. that means 1612-967 = 645 events across 7330 people (8000-967) over 19 months (dec 2017-march 2016) for a blended event rate of 5.56% from now till the end of the trial 645=7330 * 19/12 * x.
so either events toward the end of the trial are accelerating, final event horizon needs to be pushed out into 2018 or something else is going on.
perhaps t2dm in the control group are seeing more events as jl as commented on many times. perhaps v not working well. who knows.
3) as jl has also said many times, we can take comfort in jelis control group event rate as to some degree this helps find the floor for vascepa arm patients". this rate was 2.2pct in jelis although in our wildest dreams this seems low for a bunch of fat americans w t2d eating fried chicken and wonder bread no matter how much vascepa is consumed.
net net, a lot of math and prior study data is in our favor, risks on trial execution, exclusivity, data analysis and fda behavior remain.
potential partners will look at this data simililarly, i think.
yb
agreed sts - a high class problem and much better than both running out of fish oil sources and continually raping the ocean...
if reduce it is a success jl, you i and a few others can take some of our profits and by their IP and get it going!
jv
this epa/dha algae company just went bankrupt. they had great technology, developed high growth strains of algae that lived well in very warm saltwater, but there just wasnt enough market. plant based omega 3 still dominated by demand for dha for baby formula. perhaps one day it will change.
even the 40 TONS OF ALREADY PRODUCED ALGAE W 25PCT LIPID CONTENT WAS SOLD FOR PENNIES ON THE DOLLAR...
human history is filled with trash to treasure stories. perhaps there will be another here one day...
http://www.biofuelsdigest.com/bdigest/2015/07/22/rip-aurora-algae-algae-and-the-never-never/
if you read the pr carefully on full enrollment/60pct event threshold, you will see that they are requiring a followup visit by what seems to be all trial participants before analyzing the interim data.
this is what is taking the extra time. most likely they want to have not only good records of events on patients, but on lipid and other profiles just in case the trial is halted at interim. a lot of valuable info in those lipid profiles...
so add 3 months for additional follow up visits across thousands of patients to time to analyze the interim data, gets you toward the end of this year.
agreed. money saved more important than saved lives at this point in the out of control evolution of humanity...
that much after hours volume after a strong day in volume and price movement is bullish
great patient reviews on vascepa.
i havent seen these before....
http://www.drugs.com/comments/icosapent/vascepa-for-hypertriglyceridemia.html
source on 68% of diabetics die of some complication related to heart disease:
american heart association.
http://www.heart.org/HEARTORG/Conditions/Diabetes/WhyDiabetesMatters/Cardiovascular-Disease-Diabetes_UCM_313865_Article.jsp/#.VwXMpfkrJD8
since > 68% of diabetics over the age of 65 die of some form of heart disease, better understanding of average age in the trial would give us a new look into placebo rate...
does anyone have an idea?