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Seemingly, no leak so far.
It is possible that the company will just report the financials and talk about RI generally (independent to 80%IA) but give a timing to the readout, in tomorrow's CC. Then, I will read the transcript carefully later (particularly the QA section).
Larger volume (about 3M, comparing with 1.8M on average) indicates more concern from two sides (long and short). I believe that the company will publish 2Q financials AH, or even giving the 80% IA (expect to be "continuing").
Averaged Weekly TRx by Month
Jan/13 97
Aug/13 5,259
Dec/14 9,926
Feb/15 10,357
Jan/16 15,116
Feb/17 20,004
Jun/17 22,465
I believe that FDA will issue tentative approvals to some or all ANDAs on or before 7/27. Without court ruling, those tentative approvals are empty, and it takes years or decades for the court can finish the trial. And, the process will have a restart when RI sNDA comes in mid-2018. ......
Today's volume disappoints.
As first thing first in Real-Estate is "location, location, location", the first thing first for trading stock would be "timing, timing, timing". Right now is the most sensitive timing for the name of AMRN since 2013 AdCom. The good timing will go through RI 80% read-out till the completion. Catching the timing and making good money.
Buy "in-the-money" calls with an obvious winner is a winning way.
AMRN is an obvious winner.
Buying AMRN in-the-money calls can enlarge your profit with limited resource ($$). E,g., you only need $1.75 for 1 sh of Dec 2.5 Call, rather than $4.28 for 1 sh of common. I.e., you may buy 250% Call shares than common.
OBVIOUS WINNER is a must. V is a symbol of Victory. With successful RI, V sales will continuously grow up in a few years (usually, taking 7 years, from the approval, to the peak -- 2020).
Now, the stock, AMRN, is start to looking back the pre-AdCom Era ... Mary Park and Eric Coleman, AMEN. The ongoing R-I study should be installed as a Phase IV study. How about ANCHOR sNDA? I know, ANCHOR SPA was long gone, but whether ANCHOR sNDA is still alive? Could ANCHOR sNDA to be approved after the completion of RI (RI still have to go thro the its sNDA prcess I guess).
How many CHD patients died due to the absent of a much needed FDA labeling to the pure EPA. AMEN!
"ANCHOR SPA should never have been approved". I agree (just a bite set up by FDA).
However, RI SPA shouldn't be a replay of ANCHOR SPA -- because RI is a CVOT real stuff. RI AdCom (first half of 2018?) should be totally differing from ANCHOR AdCom.
For AMRN PPS, I believe it is at the beginning of a S-shape curve. The take-off will start within 8 weeks. WW's $10 TP (target price) is for the take-off only. How high will be the plateau (about 5 years later)? Hard to say at this time. We have to watch what kind of develop program the company will take. V itself is worth about $20 per share. But a right combo (V + a statin or a statin like) could push the TP to $50.
Nice to wait and see.
Thanks Sam81.
The weekly script is hooking onto 22K for about two months. I believe that only a successful RI 80% will lift it. Perhaps, one more month to wait. If the answer from RI 80% is just a "continuation", then perhaps 6 months to wait for the RI completion (triggering ANCHOR labeling in additional to MARIN's) -- huge Binary).
The last engulf was in early Feb stared from $2.8x then up to $3.42 (I sold my old position there, and re-establish a larger position @ $2.9x recently. The current engulf started from $2.9x and let us wait and see where it ends.
Re-reading 2013 ANCHOR AdCom Questionnaire:
"......
Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population.
2. 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? Please provide the rationale underlying your recommendation."
So, first thing first, ANCHOR labeling would be approved around 2017 year-end (RI 100% onset). It will be the game changer for the Share-Price landscape, followed by RI completion readout in mid-2018 (a huge Binary), RI PDUFA (6 or 10 months) and RI AdCom prior to the end of PDUFA.
Selected Weekly Scripts:
Ending___TRx____NRx
01/09/15 9,981 4,255
01/08/16 15,317 6,174
12/09/16 20,076 8,128
03/10/17 21,464 9,220
05/05/17 22,763 8,980 (Note: May 1st is a public holiday)
Generally, PCPs are conservative. They won't move fast w/o clinical data.
You can tell what would happen with any positive data from 80% Interim.
K
No change in meds (except V) and exercises (walking 5-7 days per week for many years), but did change in diet (less fat and less salt).
Study on One Subject
Time______________TG__LDL__HDL
Sep/13____________520__210___37_(starting Vascepa)
Dec/13____________303__130___54
Mar/14____________194___95___44
May/14____________89___119___37
Sep/14____________267___135___50
Apr/15____________189___142___55
Feb/16____________131___116___49
May/17____________163___122___44
With V, TG is down, so does LDL. HDL varies randomly along the normality.
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 $25.5M 239K $107 8,000
RI has enough patient*year to separate the two arms of RI in 2017!!!!
The threshold for stopping the study early is considerably higher (p<0.0076 at 60% and p<0.022 at 80%) than the threshold for defining statistical significance after the expected completion of the study (p<0.0422), which means that the study will probably be completed without an early stop.
Time CashOnHand
1Q/14: $164.9M
2Q/14: $151.1M
3Q/14: $135.4M
4Q/14: $119.5M
1Q/15: $161.2M
2Q/15: $136.0M
3Q/15: $119.0M
4Q/15: $107.0M
1Q/16: $81.4M
2Q/16: $72.5M
3Q/16: $118.0M
4Q/16: $98.0M
Jan 17 $121.0M
"100%" would be announced in October. Two more months should be enough to finish out the 20% more new cases. So, "publish" could be in December, 2017.
Needs a p less than 0.022 to stop at the 80% Interim. However, the Company may want to reach the end anyway.
Any outlook?
Estimating the onset of "80%" by middling "60%" and "100%":
"60%: late August, 2016
"100%": before the end of 2017
"middle": in April 2017
No price movement w/o further RI data disclosure.
Most PCP are conservatively follow FDA labels. So, I don't expect a jump of V Rx w/o RI success.
One of my relative has taking OmegaVia EPA 500 (because it is much cheaper than off-label V) for months and having serum A1C down from 60+ to 55.
Could you tell us TRx #
The low PPS indicates that average investors still consider RI to be a failure.
How? a) Unexpected safety issues. b) The p value difference between V arm and P arm at the end of RI is no less than 0.05.
I don't believe a) will happen. But I am looking for any signal of b} in every coming event. I'd like to say: SO FAR SO GOOD. The "80%" should be reached soon (or already). Feb Earnings would confirm the Jan PR. The announcement of 80% could be in March with a "Continuation" or "stop". The "100%" could be reached in 4Q. PPS will be trending to up side with RI unfolding and w/o b)'s presentation.
It is very possible. Let's wait and see.
Stoppage at 2nd INTERIM (80%) needs p < 0.022 -- I hope but not expect it to be happening.
The weekly Scrip:
on 1/1/16: about 14,000
on 12/31/16: about 20,000
and it will be about 30,000 on 12/31/2017.
2015 Revenue was about $82M.
2016 Revenue is about $125M.
2017 Revenue will be above $180M.
It is in an exponential mode.
Many good drugs' sales took 7 years to approach its peak (2020 for Vascepa) then keep a smaller but steady slop till its genericization (probably in 2030).
It is all about RI right now. A successful RI may fasten the positive slop BY THE PREVENTING CHD INDICATION. If RI outcomes just be so-so, then lowering TG may be enough to keep current sales level.
Happy New Year
Weekly Script breaks 20K at ATH, but PPS is staying just above $3.
The market says it all the way that AMRN is all about RI outcomes. If it is statistically significant positive, PPS will immediately break $5 then $10, $20, and then a buyout.
However, 2nd INTERIM is expected, by the market, to be spelling out as "continue".
I don't think the RI Study will be a failure (p >> 0.05 at the 2nd INTERIM). But, how about there will be another "continuing" at the 2nd INTERIM without any details. I hope not, but the low PPS just indicates that is possible.
I believe the PPS will stay around current level for a few months due to lacking of material events.
Agree.
DMC's stoppage suggestion can only happen upon ethicals (i.e., statistically significantly more patients dead with placebo than with V).
I don't believe any suggestion of a stoppage of RI prior to completion has any weight. I.e. RI won't stop before the completion. First at all, FDA shall approve ANCHOR labeling till RI completion by a 9:2 vote in OCT13 AdCom. Nevertheless, RI is in such interesting to medical community. The completion RI will bring much more than preventing CVD alone (although, preventing CVD is already a heavy weight fighter in medical history). One and half year waiting is nothing comparing with the power of RI study.
RRR is a right-hand censored stochastic variable depending on time, disease status, demographics and much more others. Observations are always carrying random errors. Whwn other variables are all set, the expectation of RRR should be a time series. However, increasing patientsXyears can narrow down errors. Such that observed RRR at 60% events is not necessarily less than that at 80% events or at the completion. Just the RRR at the completion should be more accurate than previous observed RRR.
Have a good weekend.
Idea Case:
Loaded after AdCom
Traded and increased holding along the way
Sold October/16
Loaded these days
Trade (buy low sell high) into RI completion and full load again just prior to RI completion and then increase holding along the way.
Off-label promoting ANCHOT was allowed by 1A. But I am afraid that in order to not upsetting FDA (RI is in their hand), AMRN won't promote ANCHOE before FDA's approval; and I believe FDA will approve ANCHOR upon a RI sNDA submission.
As an official record from Company's presentation:
Key clinical milestones
? H1 2016: Reach 60% target aggregate primary events in REDUCE-IT
? Sept 2016: REDUCE-IT 60% interim analysis by DMC
? H1 2017: Reach onset of 80% target aggregate primary events in REDUCE-IT
? Q3 2017: REDUCE-IT 80% interim analysis by DMC
? Q4 2017: Reach onset of 100% target aggregate primary events in REDUCE-IT
? 2018: REDUCE-IT final analysis