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Many here were discussing Options. Timing is the determinant for any options.
If you "really" believe sciences, then a "Binary" (say, RI INTERIM) is not the BEST timing for buying Calls. If V really can have some significant effect in reducing heart risks, the best timing is entering the latest in money Calls (now, Jan 2017 $0.5-$2.0 Calls) using the money affordable as early as possible, and preparing for exercise on the expiration.
Pravastatin (low or high dose) works well with V in both efficacy and safety.
I think those 6,100 Aug 19 $3 Calls (Note: not Sep or OCT Calls!!!!) are serving as an opportunistic bid. The bidder take the advantages of the positive mode on Sep/Oct RI INTERIM readout. Nothing assures the output of that readout itself.
Up 4% pps with he volume of 200K. This is an Energy STAR.
Speaking of Asia, "Asia has had high endogenous EPA" itself could be mis-concepted?
"Asia" is a very much vested area. Some areas are along the sea -- with rich EPA resources, but inland Asia are far from the sea w/o adequate EPA resources.
If "Asia" aren't living in Asia, their diet would not be "Asia" typically, and their EPA level would be changed too.
So, be careful of using "Asia" as a whole in dealing with EPA level.
Today (A Saturday!), AMRN PR about T2D, plus May 11 PR about VHTG Women, let me think about a key settlement in March 8 1A:
"• FDA has agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims."
Seemingly, AMRN has officially launched promotions in VHTG Women and T2D (may be overlapped).
The NCE will be expired on July 26, 2017. So, any ANDA challenge would not be accepted prior to July 26, 2016. Watson dismissed their law suit on NCE but they are still possible to file an ANDA challenge with a paragraph IV certification on or after July 26. Watson will try to be the first filer, but quite many others (say, TEVA, MYL, ...) will try too. I guess that we will see multi-first-filer on coming July 26.
AMRN's pps may be hit by the market-players playing on that news. But nothing would be really wrong. All filers have to face patent fight in court, and NCE (I am sure that AMRN has several patents related with NCE) indicates the fight is an up-hill one for those ANDAs. And the patent fight may take 10 years or longer (appeals after appeals) to reach the final ruling, and AMRN can sell V all along. So, I expect AMRN's pps will resume its uptrend thereafter. Sep/Oct is set up as a good time for AMRN shareholders with no doubt -- all about RI!!!!
We will be there in Sep/Oct.
Regarding with a CVOT (say, RI), one cannot separate EFFICACY and SAFETY entirely.
It's around 21st minutes.
Could you listen to the webcast. I just listened it last evening.
I don't think "early stop at INTERIM" is in the Cards.
Listening to JT, RI will continue after INTERIM, even if INTERIM shows significant efficacy. He mentioned "multiple INTERIM". So, RI has multiple INTERIM set up along the way of the trial.
I think that kiwi just weigh "early stop" too much and decide to trade upon it. Everyone can have ones own objects and planning. You can say it honestly, or you can talk and walk. Do whatever you want, "Honest" or not. We are just on a message board.
It sounds like a use patent. Academically, a use patent may not be very interesting. However, if it is very tricky then it may be, sometimes, very powerful as an IP for protecting.
It closed @1.94 4 days ago and @1.52
Per cyliu1222 on Yahoo Board:
Time_EndCash_NetBurn_Revenue_TRx_Rev/Rx_Enrolled(RI)
1Q/14: $164.9M $27.6M $11.0M 93K $118 6,800
2Q/14: $151.1M $13.8M $12.6M 110K $115 7,000
3Q/14: $135.4M $15.7M $14.1M 132K $107 7,100
4Q/14: $119.5M $13.6M $16.5M 146K $113 7,300
1Q/15: $161.2M $30.3M $15.6M 154K $101 7,400
2Q/15: $136.0M $25.2M $17.7M 176K $100 7,600
3Q/15: $119.0M $32.3M $21.3M 199K $107 7,700
4Q/15: $107.0M $12.0M $26.4M 226K $117 7,900
1Q/16: $81.4M $25.6M $25.6M 239K $107 8,000
"ANCHOR was a 12 week study with 702 patients. R-IT is a global multi-year outcomes trial with 8K patients. With R-IT, your tracking and adjudicating events on thousands of patients across the globe. With JELIS, the population under examination was only in Japan. There's greater complexity in evaluating a global trial versus a trial confined to one country."
1A doesn't have any significant effect on the stock price up to now.
I am not worrying about that too much.
The problem is that 1A doesn't push insurances at all. Insurances care about RI and RI only.
However, with successful INTERIM, AMRN can spread the RI words to insurance immediately -- don't have to wait for FDA's node (but I guess that AMRN will still play nicely any time with FDA). So, the 1A win is nice, perhaps only symbolically.
"To cover or not to cover" that is the question for shorts.
The recent huge volume shorts were at around $3. $1.9 seems to be still easy for them. However, any positivities from INTERIM will push the stock to above $5 in no time.
I like Vascepa due to its efficacy but mostly its safety. It is no way that Vascepa doesn't have effects -- just how much.
"To cover or not to cover" that is the question for shorts.
In deferring with K, it is not an issue to me whether RI will stop at INTERIM (967th). What I like to have is a positive RI, even if p is 0.07. Other 645 MACEs will bring the p value down (sample size matters).
Bad news is that the price dips a Nickle. Good news is that the volume enlarges some. If the dips keep ensmalling and volumes keep enlarging then a gap up has begun to ripen.
The VOTE questionnaire of 2013 ANCHOR AdCom is as follows:
"VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"
A successful RI INTERIM could be enough to get the ANCHOR approval and the off-label RI promotion. However, AMRN settled with FDA on that RI will run to its end even if INTERIM is a success. Such that by the language used in the above questionnaire, FDA should grant the ANCHOR label expansion to Vascepa immediately on INTERIM success -- prior to the official RI label expansion. And I believe, RI will have an expedite review separately to ANCHOR label expansion.
The flight is taking off, and the tail-wind is blowing. Bye, bye, shorts.
FDA have black-boxed Niaspan and Trilipix a few years ago. So, withdrawing niacin and FF is just a follow-up action. The new impact is on generics -- all related generics lost their ground and to be withdrawn as well. Seemingly, it is good for V.
My another guess: AMRN will do the last financing around the time of announcing INTERIM (May or June).
Too much anxieties have been presented by many posters. Why pay so much affords to guess the RRR?
My reading of March 31st PR is the company trying to employ "adjudication process" to calm down the anxieties in shareholders.
All is about RI outcomes. Seemingly, the announcement of "967th" is coming soon (in May or June), perhaps w/o any "judgement" due to "six month analysis".
could be NCE day tomorrow.
Although there are about 140K shares of $2 Calls, the $0.25 gap from $1.75 to $2 seems a little-bit wild, and previous 7-day ups, consecutively, make the PPS tired. How tomorrow (EXOP) will be is everyone's guess. My guess: the daily high will be around $2 but the PPS cannot break $2 at the close -- just a guess.
low volume + sticky pps = calm prior to storm (INTERIM? 967th will be announced anytime as the company promised to do so).
967th: a binary? Originally, I don't think so. But the market is arguing.
"So I asked when the 20,000 patient years was as of. I think there had been some questions whether it was as of the CC or end of last year. This was the response I received from Kate:
'With respect to your question, that is detail we have not publicly provided so I cannot provide any further information regarding the timing of having achieved 20,000 patient years.'
Why so secretive all the time?"
"No new issues found" = All found issues exist
"File in time (April 29)" = 1 month delay and default triggered
If they haven't had INTERIM in sight, then why they closed the enrollment door.
The fact of INTERIM occurring in late 1H itself spells for a positive (and quite possibly significant) RRR.
Things will be cleared in coming 1Q Earnings (in early May).
As the settlement was announced, I was wondering what will be future "off label"? One thought is RI trial may generate many indications other than CVD. E.g., anti-inflammatory. I weigh anti-diabetic as the most important off-label indication, and anti-depression as the second one. Both are $Bs.
From the presentation (slide #3) for Dec/15 Oppenheimer CC:
"Upcoming: Cardiovascular outcomes data on Vascepa® (>96% ethyl-EPA3) as add-on to statins ? REDUCE-IT CV outcomes study 99% enrolled ? Events driven study incorporates learnings from positive JELIS (Japan CV outcomes study of EPA) and others ? Leverages strong lipid efficacy & safety profile: two Phase 3s ? Studying at-risk patients with persistent elevated triglycerides ? CV outcomes results expected 2018, potentially 2016"
The company said they expect 967th occurring in 1H16.
And later 967th indicates higher RRR.
"H(h)ow would patients behave differently when they experienced symptoms of unstable angina if they knew they were taking 1.8g of Epadel Vs 1.8g of placebo"
Pharmacodynamically, the open-label could separate the active wilder from placebo. I.e. an open-label study could overestimate the efficacious of an effective medicine (vs placebo). Such that as many conferred JELIS, they should have taken some conservatives.
My sympathy.
BTW, your own anxiety may play a supporting-role in that, medically speaking.
"Omax3 ultra-pure is a pharmaceutical-grade* omega-3 supplement made from highly purified fish oil that delivers more than 97% pure omega-3 content and greater value. omax3's exceptional purity is a result of double molecular distillation "a process that takes place in a vacuum and uses low heat and special enzymes to get rid of unhealthy saturated fats and toxins, such as mercury, lead, and pcbs commonly found in fish. patented formula provides a 4:1 ratio of epa:dha that has been shown to significantly promote proper inflammatory responses +97% pure omega-3. 100% free of contaminants and toxins. 16x contains 1.5g of omega-3 per dose, up to 16 times more omega-3 content per serving than krill oil tested and certified by 3rd party labs to ensure purity and potency omax3 benefits benefits your heart health helps maintain healthy cholesterol levels. Lowers cholesterol without increasing ldl. essential to supporting health from your head to your feet. helps your body resolve inflammation that may cause disease and obesity. improve brain function. Improve memory. Enhance cognition. improve muscle recovery time. helps against psoraisis. helps eczema sufferers reduce symptoms *what does pharmaceutical grade mean? 1)the total long chain omega3 fatty acids must be greater than 60% of the total fatty acids. 2)the ara to epa ratio must be 5% or less. 3)the pcb level must be less than 10ppb parts per billion. get yours now to enjoy a healthier you!"
Yes, those "pure O3s" take a lot of potential beneficiaries out of pure EPA (Vascepa), even may damage patient's health. They used "pure Omega 3" to confuse with "pure EPA". But those opportunists can never do a CVOT to have a labeling for preventing CHD. They just employ grey to confuse with black/white.
In certain degrees, I believe FDA did some right things for asking clinical trial(s) wrt any major medical claims.
Seemingly, the market says: preparing for another delay on Feb 17.
Actually, the later INTERIM = the greater efficacy. The PPS may go higher with a FEB 17 Delay; but it may go down further prior to that date.
It is totally different between what the company (JT et al) said and what the hard CVOT (RI) demonstrates. FUD (low PPS) alive without trustworthy unless a positive RI INTERIM (stop or not). Just be patient -- we will be informed one week later.
It has been long expected that: the later date of 967th, the greater RRR. With 5.2%, 967th was expected in 2015 with 15% RRR. Now is already Feb 2016!!!! Current RRR should be greater than 15%. Feb 17th would be a great date.
Plausibly:
"While a blockbuster deal may not be imminent, Gilead is keeping its options open. Finance chief Robin Washington said on a call with analysts that planned repurchases could be paused if an acquisition opportunity comes up. And incoming CEO John Milligan said he plans to “work hard to help Gilead’s business grow beyond antivirals and into new therapeutic areas for the betterment of patients.”"