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In any way, the CVD sNDA submission is a major (or historical) event for the drug Vascepa and the company AMRN. But the pps of AMRN stacked way below $20.
For a long time (since 2013 ADCOM), AMRN is treated as a "frost child" by the market. RI results changed that a bit, but didn't overcome that entirely yet. About BP buyout, it should get more interesting followed sNDA submission (next week).
Whether AMRN pps will jump up or pull back with the sDNA submission, it will define the pattern of AMRN pps for 2019.
Another issue to observe is the PDUFA date. Two-month priority will jump the pps; six-month may not have too much power, and ten-month keep the business as usual.
The RX growth will be the volcano underneath the pps ground. But it is a slow process. We have to wait and see for a considerable period (the 25% RRR almost guaranteed a bright future though).
A picture is worth than one thousand words. L (G or not) is no more a concern. Does some one has the data of DS vs. V (in volumes or values, any parameter is in interesting)?
Since Oct 2013, I have re-read the follow document for more than 10 times:
********
FOOD AND DRUG ADMINISTRATION (FDA)
Center for Drug Evaluation and Research (CDER)
Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)
FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center
(Rm. 1503), Silver Spring, MD
October 16, 2013
DRAFT QUESTIONS
Page 1 of 1
1. DISCUSSION:
In ANCHOR, 12 weeks of treatment with Vascepa 4 g/day led to an estimated median -21.5% (95% CI, -26.7% to -16.2%; P<0.0001) change in fasting triglycerides, compared with the mineral oil placebo, among statin-treated patients with mixed dyslipidemia at high cardiovascular risk. Changes in other lipid/lipoprotein parameters (selected secondary and exploratory endpoints) are summarized in the table below.
Median % Change from Baseline to Week 12
Median % Change
(95% CI)
Placebo
Vascepa 4g/day
Treatment Difference
Fasting TG
+5.9
-17.5
-21.5 (-26.7, -16.2)
Direct LDL-C
+8.8
+1.5
-6.2 (-10.5, -1.7)
Non-HDL-C
+9.8
-5.0
-13.6 (-17.2, -9.9)
VLDL-C
+15.0
-12.1
-24.4 (-31.9, -17.0)
Apo B
+7.1
-2.2
-9.3 (-12.3, -6.1)
Tot. Chol.
+9.1
-3.2
-12.0 (-14.9, -9.2)
HDL-C
+4.8
-1.0
-4.5 (-7.4, -1.8)
Apo A-I
+3.6
-2.9
-6.9 (-8.9, -4.9)
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.
********
I think FDA did a very right decision. Now, I am waiting FDA to do another very right decision: Approve REDUCE-IT sNDA ASAP followed its submission (in coming March). And I believe FDA will -- it's about saving lives. I expect the approval will come out in July or August.
Talking about Vascepa's commercialization, GIA is a very slow approach for tiny Amarin. I am looking for a partnership or a buyout. I prefer a BO more than a partnership, because I am just an individual investor (my investment is concentrated on AMRN), a lumpsum is perfect to me. 5+ years is a long way, but not a length of time can measure success. It is your homework and your confidence on your homework. I am so glad we longs get award.
I worked at and then retired from UCSF. My PCP (a colleague) prescribed Pravastatin 20 mg and OTC fish oil (2g/d) to me 20 something years ago (before Y2K) to treat my high lipid profile, then changed fish oil 2g/d to Vascepa 4g/d since 2013. My blood tests have shown acceptable lipid parameters -- now, my BP is about 130/70, HB is about 66, and Total LDL is about 100.
I read 2013 AdCom Documents once again and thought FDA can make judgements to RI results based on 2013 AdCom's conclusions, such that no need to calling on any new AdCom.
Now, FDA needs to decide a PDUFA date for RI sNDA.
If PFE is really intending to take-over and there are other bidders, tomorrow will be a good time for a muscle show. I am looking for an unusual high volume (not necessarily with high PPS though).
I built my position followed 2013 AdCom. Currently, having 120K shares averaged around $5 (9/24/18 gave my account 200% profit). I took out some small proportion and keep the rest.
I believe this stock is in low risk followed 9/24/18 results. I will keep my shares except taking some out for 2018 Tax.
I will take a ride toward a BO or on anyway AMRN does.
I remember that JT said that the sNDA submission and EU partner will be announced in late 1Q (late March?). Waiting to see movement on March Options.
Today's trading volume is capturing the 3m Average Volume with upping PPS.
On Sep 24, 2018, the PPS jumped from $2.99 (9/23 Close) to $10.44 at Open, then closed at $12.40.
Today (1/3/19), the PPS Open was a bit above $12.40, but may close nearby.
Three issues have impacted: RX, sNDA Submission and EU marketing.
New REPs just start their works this week, so we wouldn't see the RX increase significantly for a while. And sNDA and EU marketing could happen weeks later. Such that now is the dark prior to dawn. Unfriendly Make Makers just take the chance to attack the PPS to produce sellers. ......
Right now, the chart shows a most pretty EVENING STAR --Coming 2019 Spring WILL be sunny and warm to AMRN shareholders.
Patience is essential here.
As a record, PPS closed at $11.xx.
By my understanding, many longs were accumulating this stock followed ADCOM. Their costs, now, could be from $1.xx to $5.xx prior to 9/24. Some of them may take some profit after the jump. But I suppose that many longs still hold their core position waiting for next big events (sNDA, EU expansion, label change -- RI approval), ... Yes, long-term capital gain could be another consideration.
Anyway, I am not in a hurry to sell my core position below $20, while $30+ is definitely coming in sight of 25% RRR and 20% CV death reduction.
Patience is essential here!
Christmas is coming and the year is getting the end.
2018 is the KEY-STONE year for AMRN. At 2013 OCT ADCOM, many shareholders were slumped, but kept their hopes alive for 2018 September RI results.
It is a most wonderful September for us. 25% RRR and 20% reduction on CV death are historic. AMRN closed at $2.99 on 9/21 (Friday), then open at$10.44 on Monday 9/24 -- 350% jumped. A few weeks later the PPS breaks $23.
Vascepa is a wonderful CVD drug. It save lives. But not too many patients and Doctors have heard about Vascepa yet. The awareness can be shown by the RX number (say, weekly TRX). According to Sam's data, TRX was 333 in Jan 2013; broke 10K in Jan 2015; broke 20K in Dec 2016, broke 30K in Oct 2018, and now is at 35K. RX numbers will be the best indicator for us. Now, it is still at low levels.
RI results, AHA presentation, sNDA submission, EU marketing, and FDA labeling change all do its jobs to move the RX number to a new level. But the defusing (to patients and doctors) takes time.
AMRN PPS may drop in late Dec, but will be up huge in 2019.
Patience is essential here.
Happy Holidays.
FYI -- weekly TRX
10/05 30,567
11/02 30,956
11/16 32,548
11/23 28,898 (Thanksgiving)
11/30 33,963
12/07 35,142
Anybody has the weekly script number? TIA
Today's anemia volume indicates that the market is waiting for SOMETHING. And $18/$25 spread of Dec 21 Calls provide a clue. That SOMETHING isn't sNDA/EURO (those should come out at early 1Q19).
Do you remember the past $4/$7 spread? AMRN jumped from $4 to $15 on 9/24. Huge Option positions always provide a serious clue. But the ordinary only get the fact afterwards.
Be patient.
For shareholders, now are in a sales GAME. If RX # running higher, so does PPS, generally speaking.
Sam's data give us a reliable comparison weekly (thanks to Sam). Last week, TRX was about 34,000. If add 1,000 RX each week, TRX would reach 38K at yearend -- it is a symbol for the company achieves cash flow positive.
The good news is AMRN will start to have positive earnings; the bad news is there will be a long way to go to have a meaningful income.
Be patient.
Tomorrow will be a huge upward day of the boarder market, and AMRN would ride the tide toward its 52W high with increasing sales.
Selected Average Weekly TRX (based on Sam's data) by Month:
Year Month TRX
2013 Jan 97
2015 Feb 10,357
2017 Mar 20,000+
2018 Oct 30,000+
2018 Nov 32,000+
It took 25 months from 0 to 10,000, and another 25 months from 10,000 to 20,000, about 19 months from 20,000 to 30,000. Now, it may take only 4 months (Nov 18 to Feb 19) from 30,000 to 40,000.
Seemingly, the offer was priced at $17.64 per share.
Today's trading, so far, suggests that the offer would be priced as $17 per share. Friday should be an up day (and an upward RX number should push that).
FCC and SEC!!!!
No way.
Today's drop may cause quite many Margin Calls.
"Current" (or previous) short position is 6M shares.
"Believe what's unbelievable"
At AHA, Nov 16, RI had 25% RRR and 20% reduction on CV death; but AMRN PPS down to $15 -- MMs made a lot of Option worthless (they saved by no pay off to Options.
Today, with secondary offer (consolidating V's potential), AMRN PPS down to $16. We will see the offering price soon (in two days). I am almost sure the offering price would be very much higher than $16. But I don't know how MMs make money this time, at least they can cover their short positions.
Getting patents back should regain the full valuation to the company. Why AMRN's PPS was under $4 before 9/24, the patents situation is one reason.
This relatively small offer should be the last. I don't know how market reacts to this. But my experience told be, the last offering of a company with a strong potential may not drag the PPS, in contrast quite many time a good company's PPS would raise after the last offering (particularly this offer is such a small one). Let's see.
Today's offering announcement indicates that BO is not an option in the near future. But a partner is still in sight due to that AMRN is too small to sell the giant product in the world. And an up front payment will be applied (so the current offer is such a small one). I do expect that AMRN will announce the partnership soon.
I bought 10K shares at AH with $18.20 per share. Now my base is up from $3.7s to $4.7s..
If my memory serves me good, it is $100M with royalty sharing. Now, royalty is coming, so this loan will stay there for a while.
Seemingly, AMRN becomes a matured stock. No more jumps like one of 9/24/18.
A BO is still insight. But quite many staffs still sticking around.
First at all, does AMRN interest in a BO (even with fair value)? Or they would like to GIA or partnering? It is not clear as now. For a drug like V, GIA seems too thin in considering of huge PCP market. Partnering is a doable way, but finding a suitable partner is a must. BO may be great but in what term(s). I think that AMRN doesn't have a clear clue yet. Themselves are in searching a suitable way.
Currently, RX number is the only reliable way to give us a glim of commercialization of V. Sam's number doesn't tell us the whole, but his number is stable and reliable to represent the commercialization of V. Much thanks to Sam.
Be patient. The game is in the second inn, though the game changer has already been showing up. Wait and see!
My suggestion to all longs:
keep some powders in your bank for living and let the rest going with AMRN, no matter they GIA or get a BO. I believe the ending is beginning.
Seemingly, V's TRX (based on Sam's Report) would reach 38K prior to the yearend. It will be the time of AMRN's cash flow breaking even then turning to positive. PPS should top $30 in 1H19.
The 3M shares Jan 18 2019 $21 Calls and Puts (supposed from the same Fund or Funds) are betting on VOLITILITY! I.e., betting on V prescripts would be very great or very disappoint. Let's follow Friday-Sam every week. It will give us a clear clue.
700K (mclim)
From the high of $23 to AHA's $15, it's $6 reduction (but what is your basis on premarket Sep 24th? Many longs were at $2-$4). Quite many longs on this board held more than 100K shares (kiwi may have the record). Such that "losing 700K" would not be unexpected. However, If one didn't sell the shares, the losing is only on your calculator for now. With such reductions on MACE, AMRN will be a $50 stock in mid 2019. Take the "paper losing" easy and hold your shares tight, buddy.
Have a good-night sleep.
I don't know when AMRN will submit the sNDA, and I don't know how long FDA taking for reviewing. Never mind, the AHA pushed V sales. We will see V prescriptions flying. RX is money -- That's it.
As I always saying: be patient (this time is "months", if not "weeks").
Fortunately, the RRR and CV Death from RI are 25% and 20% (with p < 0.001), respectively. MO can never pull those effect back to p > 0.0426. I don't think MO will be an issue for FDA approval. MO has prolonging clinical-history in literatures. FDA has known that. The most is doing a P IV study (as a record for reference) to compare MO + statin (used in RI) against statin (used in RI) in LDLC.
In my view, MO was not real issue. It is just a fake issue for hitting AMRN's PPS to expire related options (with huge open interest).
For next week, the lingering margin calls may still impact the PPS for a day or so. Then the PPS should be heading to where it should be ($30 prior to BO -- BP want V badly).
"Worry about the market"?
The best way is off the Margin. W/o margin, one can keep own shares, no matter how shacking the market does. I am doing that -- I don't use margin at all. Even I did not care AMRN is marginable or not.
I am holding a quite large position on AMRN.