The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )
- Thread starter Tug life
- Start date
**** A post from Hamoa (patent attorney) ihub. On AMR 102..
My guess is that the Vascepa/statin combo capsule will be the primary delivery platform. From a potential BO perspective, the opportunity for someone like Pfizer to restart the exclusivity clock on a market leading CV med (Lipitor/Vascepa), that reduces CV risk by 50%, is pretty extraordinary. Alternatively, Amarin could out-license Vascepa to multiple statin manufacturers (the Microsoft OS model), which could broaden their market coverage. A third model (albeit less likely) would be Amarin unilaterally marketing a Vascepa/statin combo. Considering that statins have for the most part been totally commodified, the third approach is not out of the question in my view. Consider the opportunity for any one company that could exclusively offer 50% CV risk reduction.
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My guess is that the Vascepa/statin combo capsule will be the primary delivery platform. From a potential BO perspective, the opportunity for someone like Pfizer to restart the exclusivity clock on a market leading CV med (Lipitor/Vascepa), that reduces CV risk by 50%, is pretty extraordinary. Alternatively, Amarin could out-license Vascepa to multiple statin manufacturers (the Microsoft OS model), which could broaden their market coverage. A third model (albeit less likely) would be Amarin unilaterally marketing a Vascepa/statin combo. Considering that statins have for the most part been totally commodified, the third approach is not out of the question in my view. Consider the opportunity for any one company that could exclusively offer 50% CV risk reduction.
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***From YMB
Early FDA approval of sNDA for Vascepa very likely after ADCOM mtg. Multiple precedents have occurred with FDA announcing early approvals of NDAs or sNDAs in the last year. XRLN's NDA got approved yesterday way ahead of Dec. 4 PDUFA date. It was also granted Priority Review just like Vascepa's sNDA. I expect a decision on sNDAs to come quicker as those drugs are already approved & marketed, and FDA is already familiar with the drug especially with Vascepa's case which got denied in 2013 for their submission to treat trigs 200-499. No reason for FDA to wait until 12/28/19 for announcement of approval of Vascepa expanded label. The ADCOM mainly delayed the whole process of getting an expanded label under a Priority Review. Christmas gift for AMRN Longs will come early this year!
Just a bit more info, so you got get caught waiting to long.
***edit
Stifel analyst Derek Archila is optimistic that Vascepa’s label expansion will be approved shortly after completion of the AdCom, noting that “Our diligence with regulatory experts get us comfortable in an FDA approval for a Vascepa label expansion to include reduction in CV risk based on the REDUCE-IT results in early 2020.”
Once that happens, an expanded label could increase the total addressable market “by a factor of 20.” The analyst added, “Vascepa’s REDUCE-IT study results are impressive, and based on our physician survey, will most certainly lead to robust growth, likely ahead of management’s 2019 guidance.”
There's an Opportunity Brewing in Amarin (AMRN) Stock Ahead of Vascepa's AdCom, Says Analyst
Planned to get some while it was struggling yesterday in the 16.90 range, didn't know TD only has instant deposit for stocks not options since that's not stated on the website
Looks like Wed is the earliest I can buy so I'll wait for the low of the day and buy then. I think it'll slow rise until Thurs when it pops so it sucks to miss out on the build up, but there's still money to be made.
***From ST
According to ICER, 12.6 million Americans will be eligible for Vascepa each year.
From p.66 of ICER's 10/17/2019 report: "For icosapent ethyl, at the the price of $1,625 per year, approximately 4% of eligible patients could be treated in a given year without crossing the ICER potential budget impact threshold of $819 million. Clinical experts at the public meeting said that they believe the majority of eligible patients would want to be on icosapent ethyl."
0.4 * (eligible patients) * $1,625 = $819 million = 12.6 million eligible patients.
12.6M patients * $1,625 net annual price = $20.5B annual sales.
3x multiple = $61.5B company valuation = $172 per share
^^^Give me $172 ps, and Ill be heading towards an early retirement within 18 months, or so.
One can only dream tho.
According to ICER, 12.6 million Americans will be eligible for Vascepa each year.
From p.66 of ICER's 10/17/2019 report: "For icosapent ethyl, at the the price of $1,625 per year, approximately 4% of eligible patients could be treated in a given year without crossing the ICER potential budget impact threshold of $819 million. Clinical experts at the public meeting said that they believe the majority of eligible patients would want to be on icosapent ethyl."
0.4 * (eligible patients) * $1,625 = $819 million = 12.6 million eligible patients.
12.6M patients * $1,625 net annual price = $20.5B annual sales.
3x multiple = $61.5B company valuation = $172 per share
^^^Give me $172 ps, and Ill be heading towards an early retirement within 18 months, or so.
One can only dream tho.
REDUCE-IT® USA Results, in Prespecified Subgroup Analyses of Landmark REDUCE-IT Global Study, Showed Robust Cardiovascular Risk Reductions Across a Variety of Study Endpoints, Including Cardiovascular Death and All-Cause Mortality
Additional prespecified cardiovascular endpoints in which the REDUCE-IT USA subgroup showed significant relative risk reduction included myocardial infarction, cardiovascular death, and stroke, similar to the full cohort in the overall REDUCE-IT global results.1 These results were incremental to the cardiovascular risk reduction achieved by conventional therapy administered to the high-risk patients studied, including incremental to statin therapy.
In the REDUCE-IT USA subgroup, 3,146 patients (38.5% of the full trial cohort) were randomized and followed for a median of 4.9 years; 32.3% were women, 9.7% Hispanic. USA placebo patients had a higher primary endpoint event rate compared with the full cohort (67.4 versus 57.4 per 1,000 patient-years, respectively). The primary endpoint (5-point MACE) occurred in 24.7% of placebo versus 18.2% of icosapent ethyl patients (HR 0.69, 95% CI 0.59-0.80, p=0.000001); the key secondary endpoint (3-point MACE) occurred in 16.6% of placebo versus 12.1% of icosapent ethyl patients (HR 0.69, 95% CI 0.57-0.83, p=0.00008). All prespecified hierarchical primary and secondary endpoints were significantly reduced in the USA subgroup, including myocardial infarction (8.8% to 6.7%, HR 0.72, 95% CI 0.56-0.93, p=0.01), cardiovascular death (6.7% to 4.7%, HR 0.66, 95% CI 0.49-0.90, p=0.007), stroke (4.1% to 2.6%, HR 0.63, 95% CI 0.43-0.93, p=0.02), and all-cause mortality (9.8% to 7.2%, HR 0.70, 95% CI 0.55-0.90, p=0.004). In the full study cohort, there was a trend towards a reduction in all-cause mortality, with each of these other primary and secondary endpoints also achieving statistical significance in the full study cohort. Safety and tolerability findings in the USA subgroup were consistent with the full study cohort.
Yahoo is now part of Verizon Media
Lets GOOOOOOOOOOO!!!!!!!!
Additional prespecified cardiovascular endpoints in which the REDUCE-IT USA subgroup showed significant relative risk reduction included myocardial infarction, cardiovascular death, and stroke, similar to the full cohort in the overall REDUCE-IT global results.1 These results were incremental to the cardiovascular risk reduction achieved by conventional therapy administered to the high-risk patients studied, including incremental to statin therapy.
In the REDUCE-IT USA subgroup, 3,146 patients (38.5% of the full trial cohort) were randomized and followed for a median of 4.9 years; 32.3% were women, 9.7% Hispanic. USA placebo patients had a higher primary endpoint event rate compared with the full cohort (67.4 versus 57.4 per 1,000 patient-years, respectively). The primary endpoint (5-point MACE) occurred in 24.7% of placebo versus 18.2% of icosapent ethyl patients (HR 0.69, 95% CI 0.59-0.80, p=0.000001); the key secondary endpoint (3-point MACE) occurred in 16.6% of placebo versus 12.1% of icosapent ethyl patients (HR 0.69, 95% CI 0.57-0.83, p=0.00008). All prespecified hierarchical primary and secondary endpoints were significantly reduced in the USA subgroup, including myocardial infarction (8.8% to 6.7%, HR 0.72, 95% CI 0.56-0.93, p=0.01), cardiovascular death (6.7% to 4.7%, HR 0.66, 95% CI 0.49-0.90, p=0.007), stroke (4.1% to 2.6%, HR 0.63, 95% CI 0.43-0.93, p=0.02), and all-cause mortality (9.8% to 7.2%, HR 0.70, 95% CI 0.55-0.90, p=0.004). In the full study cohort, there was a trend towards a reduction in all-cause mortality, with each of these other primary and secondary endpoints also achieving statistical significance in the full study cohort. Safety and tolerability findings in the USA subgroup were consistent with the full study cohort.
Yahoo is now part of Verizon Media
Lets GOOOOOOOOOOO!!!!!!!!
AMRN is up 16 percent premarket
James Carter
n/a
i got more in yesterday but my other account took till today to push my money through
i got more in yesterday but my other account took till today to push my money through
I think its going to be volatile all week. This feels like the work of shorts so I’m expecting it to drop back off during the day.
I bought mad shares yesterday at $16.91
Tug life
I stay fly like a guillemot
Amarin and Acasti both up around 19% today. Acasti follows Amarin up and down
I definitely see Amarin getting bought out in the next year one of the purest plays in small pharma right now