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SunTrust Update #1: https://drive.google.com/file/d/0B1gB2YESBJV7WkZ1UDRFMWZkWUE/view
Oppenheimer Update: given the unexpected NCE designation and ANCHOR free-speech victory, Amarin may be in a position to attract strategic interest, which could re-value the company favorably for investors.
Link: https://drive.google.com/file/d/0B1gB2YESBJV7NEo4ZDNtbzhkd1k/view
Ur welcome...from ST since 2012. :):)
The Court determined that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and specifically make to healthcare professionals the following truthful and non-misleading statements:
Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Vascepa should not be taken in place of a healthy diet and lifestyle or statin therapy......................
finally HALTED
Reuters:
Amarin scores early victory in fish oil marketing lawsuit (RTRS)
Today at 09:07
Aug 7 (Reuters) - A U.S. judge has barred the U.S. Food and
Drug Administration from stopping Irish drugmaker Amarin Corp
(AMRN.O) from promoting its fish oil drug off label, ruling that
the company is protected by the First Amendment.
The preliminary order by U.S. District Judge Paul Engelmayer
in Manhattan on Friday means that Amarin can promote the pill to
doctors for off-label use as long as it does so truthfully.
and it was highly looked at by all, a precedent in terms of relationship with the FDA
Can anyone post the pacer documents please....and email IR to announce this huge news
can you please post the 71 pages...much appreciated
where did u get that.....odd no IR from Amarin
I second that Zum...Thanks JL for sharing all this and also thanks to the contribution of all the board members
Scripts Update for week ending Week 31/07
V:
TRx:12,741{vs 12,683;+0.46%} Sec +2.49%
NRx:5,514 {vs 5,422;+1.70 %} Sec +1.60%
Ref:7,227 {vs 7,261;-0.47%} Sec +3.06%
L:
TRx: 5,062{vs 5,107; -0.88%}
NRx: 1,779{vs 1,740; +2.24%} WTF !!!
GenL:
TRx: 69,455{vs 67,348; +3.13%}
NRx: 26,532{vs 26,131; +1.53%}
V TRx Mkt Sh:14.60% vs 14.90%
V NRx Mkt Sh:16.30% vs 16.29%
V Ref Mkt Sh:13.53% vs 14.01%
TRx Breakeven Level:
As per JT in the conf call "so off of last year's sort of December prescription levels, we had commented that, at that point in time, we needed to roughly double our prescription growth in order for us to breakeven on a commercial basis.
And I define commercial basis as being our cost excluding our R&D costs. And that guidance hasn't changed at this juncture."
2-Jan-15=9,516
26-Dec-14=8,508
19-Dec-14=10,539
Fair level would be around 20K for BEven on a commercial basis. Few extra thousand in TRx to include the R&D Costs
Earning Call Transcript; for those who missed it: https://drive.google.com/file/d/0B1gB2YESBJV7TEpleV9rLXpMTEE/view?pli=1
For BB from talleyville0311 on ST
bsfllp.com/lawyers/data/2089
"huge political ties and knowledge to take on anyone. Advised this White House on Constitutional law? LmAO!! They've killed the constitution"
Suntrust Update --- Earning preview. Maintain $6 Price Target: https://drive.google.com/file/d/0B1gB2YESBJV7bnZ1LXhjVHgwa3M/view
Simple Comparison 2014 - 2015:
Week 03-Jan-14 to Week 25-July-14, Total TRx = 211,518
Week 03-Jan-15 to Week 24-July-15, Total TRx = 336,331
---> +59%
And that's without promoting V officially off-label and educating physicians
Long & Strong -- Patience is a Virtue
Script Update for Week ending 24/07
– V –
TRx: 12,683{vs 12,767;-0.66%} Sec -0.83%
NRx: 5,422 {vs 5,649;-4.02 %} Sec -1.71%
Ref: 7,261 {vs 7,118;+2.01 %} Sec -0.26% ATH
L:
TRx: 5,107{vs 5,257; -2.85%}
NRx: 1,740{vs 1,775; -1.97%}
GenL:
TRx: 67,348{vs 67,830; -0.71%}
NRx: 26,131{vs 26,448; -1.2%}
V TRx Mkt Sh:14.90% vs 14.87% ATH
V NRx Mkt Sh:16.29% vs 16.68%
V Ref Mkt Sh:14.01% vs 13.70% ATH
Thank you JL for the clear summary
Thx Tort & Zip for your reply and elaboration
Exactly my point TortLaw...that is astonishing and absolute cr&^ from the FDA. i am not that familiar with the law in the states, but this should lead to a suit reclaiming lost funds from FDA for marketing & Selling V from the adcom onwards (Marine & Anchor)
Its 2:31am my time :):) thx for posting, looking fwd to get ur feedback tmw
I'm having a quick read...point 72 is interesting:" government admits that the anchor study was not designed to measure the impact of vascepa on cardiovascular risk....." WTF, this means that it should have been approved...correct me if I'm wrong pls!!
Official: Israel's Teva Pharmaceutical to buy Allergan's generic pharmaceuticals business
Israel's Teva Pharmaceutical on Monday said it is purchasing Dublin-based Allergan's generic pharmaceuticals business for $40.5 billion.
The Israeli pharmaceutical giant is the world's largest generic drugmaker. It said in a statement that the acquisition would provide patients with more access to affordable medicines.
Statements from both companies say the deal will see Allergan receive $33.75 billion in cash and shares of Teva valued Monday at $6.75 billion.
Teva said Monday it had withdrawn its proposal to purchase rival generic-maker Mylan after reaching the agreement with Allergan.
Separately, Teva reported second-quarter profit that beat estimates and raised its full year 2015 outlook.
In preliminary results, Israel-based Teva said it earned $1.43 per diluted share excluding one-time items in the April-June quarter, 15 percent higher than a year earlier.
Revenue slipped 2 percent to $4.97 billion but rose 6 percent excluding the impact of foreign exchange fluctuations and the sale of U.S. over-the-counter plants.
Teva was forecast to have earned $1.31 per share in the second quarter on revenue of $4.91 billion, according to Thomson Reuters I/B/E/S.
Teva will publish full results on Thursday.
It raised its 2015 EPS estimate to $5.15 to $5.40 from $5.05 to $5.35.
The results "further demonstrate Teva's continuous momentum and significantly strengthened fundamentals, improved generics and specialty businesses and ability to drive organic growth," said Teva Chief Executive Erez Vigodman.
Teva is Israel's largest drug company and has long been a source of pride for Israelis. The company dates back to 1901, when its founders launched a small importer of medications. According to the company's website, it began producing drugs in the 1930s.
—CNBC and Reuters contributed to this report.
Great Scripts Data for Week 17/07 – V –
TRx: 12,767 {vs 12,305;+3.75%} Sector +0.42% ATH
NRx: 5,649 {vs 5,132;+10.07%} Sector +2.20% ATH
Ref: 7,118 {vs 7,173;-0.77%} Sector -0.71%
L:
TRx: 5,257 {vs 5,254; +0.06%}
NRx: 1,775 {vs 1,837; -3.38%}
GenL:
TRx: 67,830 {vs 67,937; -0.16%}
NRx: 26,448 {vs 26,173; +1.05%}
V TRx Market Share: 14.87% vs 14.39% ATH
V NRx Market Share: 16.68% vs 15.48% ATH
V Ref Market Share: 13.7% vs 13.7% = to ATH
ANAC 52W Low/High: 15.11 / 85.79 (now pre-mkt at 130.01)...so all is possible once corruption stops and things are back into normal via the law. With Red-it positive results, we might have a very similar pattern in terms of stock price. Long Term is the keyword
The most interesting part is the 3-6m prior to full enrollment; if analyses suggest the nb of patients is consistent with projections -->continue towards 7990 patients. If nb of events appears less than and inconsistent with projections, the sponsor will recalculate nb of needed patients to achieve nb of target events...i guess we are in the 3-6m period & no PR issued yet mentioning the need to increase patient nbs. Positive for red-it as all is consistent with projections
Your thoughts are highly appreciated it especially ZUM / JL / BB / HB...and all the rest :)
Totally lost it :) I thought July 4 was a Friday, just realized that it was July 3, that's why...so forget the unaccounted part
So ricardoga, what logic did u use, please enlighten us. You should remember that it was a short week due to the 4th of July holiday and despite that there was an increase in scripts (moreover, which is confusing, the data is for week ending 02/07, which is odd...July 03 is unaccounted for as it seems). Anyhow if you have the historical data and plot them into a graph with the trend-line, the data is still fitting into the trend-line and if that continues as it is (with no changes in label/promotion...etc) the forecasted trend-line shows very promising numbers in the future (short term, ie coming 12m)
Scripts Update for Week of 02/07
For a short week, numbers are fine
Looking fwd for a decision from the judge today and a halt :)
– V –
TRx: 12,194 {vs 12,030; +1.36%} Sector +4.29%
NRx: 5,142 { vs 5,330; -3.53%} Sector +0.02%
Ref: 7,052 { vs 6,700; +5.25%} Sector +7.05% ATH
L:
TRx: 5,389 { vs 5,437; -0.88%}
NRx: 1,744 { vs 1,791; -2.62%}
GenL:
TRx: 70,270 { vs 66,770; +5.24%}
NRx: 26,152 { vs 25,912; +0.93%}
V TRx Mkt Share: 13.88% vs 14.28% last week
V NRx Mkt Share: 15.56% vs 16.14% last week
V Ref Mkt Share: 12.87% vs 13.08% last week
I doubt new all time high. Last week was a short week bcz of 4th of July...Scripts should be back to normal weekly uptrend withb the 1st observation on Friday 17/July/2015
Scripts Data Week 26/06
Sector is down all across the board
– V –
TRx: 12,030 {vs 12,158;-1.05 %}Sector -3.26%
NRx: 5,330 {vs 5,284;+0.87 %}Sec -3.11%
Ref: 6,700 {vs 6,874;-2.53 %}Sec -3.35%
L:
TRx: 5,437 {vs 5,410; +0.50%} WTF!!
NRx: 1,791 {vs 1,752; +2.23%} WTF!!
GenL:
TRx: 66,770 {vs 69,504; -3.93%}
NRx: 25,912 {vs 27,059; -4.24%}
V TRx Mkt Sh: 14.28% vs 13.96% last week ATH
V NRx Mkt Sh: 16.14% vs 15.50% last week ATH
V Ref Mkt Sh: 13.08% vs 12.98% last week (ATH 13.19% week of May 22)
BB, Any update on pacer regarding Amarin's reply and filed response...Should we expect that today? Thx
John, i guess this shows that once approved in China, V will be better accepted and have an impact way more than in the US bcz of the FDA political stand and role and most of all corruption. China will turn out to be a way bigger market than the USA and hopefully the struck deal with Eddingpharm will be reflected in teh financials and stock price in the medium term
Scripts Update: Week 19/06 – V –
TRx: 12,158 {vs 12,205; -0.39%} Sector +1.30%
NRx: 5,284 {vs 5,412; -2.37%} Sector +0.74%
Ref: 6,874 {vs 6,793; +1.19%} Sector +1.67%
L:
TRx: 5,410 {vs 5,730; -5.58%}
NRx: 1,752 {vs 1,895; -7.55%}
GenL:
TRx: 69,504 {vs 68,017; +2.19%}
NRx: 27,059 {vs 26,538; +1.96%}
V TRx Mkt Sh:13.96% vs 14.20% last week
V NRx Mkt Sh:15.50%vs 15.99% last week
V Ref Mkt Sh:12.98%vs 13.04% last week
Short Interest Update: -8.05%
15/6/2015: 23,210,238 Change: -2,032,348 Days to Cover: 11.77
29/5/2015: 25,242,586 Change: -77,697 Days to Cover: 6.29
15/5/2015: 25,320,283 Change: -404,439 Days to Cover: 14.12
Week 12/06 – V –
TRx:12,205{vs12,451;-1.98 %}Sector -3.99%
NRx:5,412{vs5,406;+0.11%}Sec -2.97%
Ref:6,793{vs7,045;-3.6%}Sec -4.65%
L:
TRx: 5,730{vs 5,982; -4.21%}
NRx: 1,895{vs 1,801; +5.22%} WTF!!!
GenL:
TRx: 68,017{vs 71,094; -4.33%}
NRx: 26,538{vs 27,673; -4.10%}
V TRx Mkt Sh:14.20% vs 13.91% last week ATH
V NRx Mkt Sh:15.99% vs 15.50% last week ATH
V Ref Mkt Sh:13.04% vs 12.89% last week ATH
A question; Can i be part of this action if i live outside the US...Looking forward for your reply. if there are no restrictions, please send me your email to communicate directly
Thanks