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If FDA is truly unbiased and has scientific backbone, it should at least approve Vascepa for patients with TG>200 and HDL<35. FDA don't even consider the subgroup analysis of ACCORD, AIM-HIGH and JELIS and apply some basic risk/benefit analysis of Vascepa for the well being of citizens. If I have never got involved with Amarin, I wouldn't have known that FDA is such an untrustworthy entity. That's a very important life lesson that will serve me well in the future.
I have 276K shares traded as of 2:45pm EST.
JL, Dr. Sears' OmegaRx 1000mg consists of 400mg of EPA and 200mg of DHA (see link)
http://www.amazon.com/Dr-Sears-OmegaRx-Fish-Oil/dp/B008140GFQ/ref=sr_1_1?s=hpc&ie=UTF8&qid=1438691937&sr=1-1&keywords=dr+sears+omega+rx
I assume Dr. Sears used his own pills for the AA/EPA table. So 4g of EPA corresponds to > 7.5 pills in his AA/EPA table.
AA/EPA ratio info. from Dr. Sears,
http://www.drsears.com/resources/cellular-inflammation-testing/
Clinical Feature: The Triglyceride Enigma,
https://www.lipid.org/node/1325
80% probability of trial stops at interim is not a bad odd at all. Obviously, the market is not as optimistic as us die hard AMRN long. AMRN should be worth at least $10 if stop @ interim while lost at most $1 if trial continues till end of 2017.
fair value = .8*8 +.2*(-1) = $6.2
Does anybody know if ACCORD, AIM-HIGH, THRIVE and Jelis only enroll patients with a history of CVD? What's the actual event rate for ACCORD, AIM-HIGH and THRIVE? Since we know the medium TG for those trials, perhaps we can draw some insight of event rate as function of TG level.
HD, please don't let the board hanging regarding "have a different thought about one point". TIA.
HD, which trial that give you such result: "The results were mixed (low TG reduction, but significant CVE reduction and / or high TG reduction, but non-significant CVE reduction".
A link or name of such trial will be helpful. TIA.
Since when was FDA so nice to Amarin by giving it extra 3 years of NCE? You should know that's impoosible.
Another article on 1st case,
"The third communication provision sets a deadline for the FDA's repeatedly delayed further guidance on off-label communication. Related to that, in the New York courtroom last Tuesday, off-label enforcement was the point of discussion. The argument did not go well for the FDA as the agency staunchly defended existing off-label marketing restrictions and refused to set a timetable for issuing guidance.
There, eminent First Amendment litigant Floyd Abrams argued for the plaintiff, drugmaker Amarin, that the court should file a preliminary injunction restraining the FDA from enforcing certain off-label restrictions on Amarin's marketing communications. The Amarin court challenge was set up by two major federal court decisions casting doubt on the constitutionality of off-label restrictions: the 2010 US Supreme Court decision, Sorrell v. IMS Health, striking limits on drug marketing in Vermont; and the 2013 federal appeals decision, US v. Caronia, invalidating the conviction of a drug detailer for sharing truthful and non-misleading information that was off-label.
Early in the argument, Abrams stipulated that Amarin intended to engage in proactive, promotional, off-label speech. Much of the subsequent discussion turned on what disclaimers needed to accompany that speech, not whether Amarin has a right to speak.
Later, the FDA's lawyer argued for a very narrow interpretation of Caronia, emphasizing that the decision turned on a faulty jury instruction. Paul Engelmayer, a federal judge for the US District Court for the Southern District of New York, disagreed, noting that the decision in his view stood for the proposition that truthful, non-misleading speech was constitutionally protected—even when it was proactive and promotional. A judicial order is expected within two to four weeks.
Bottom line, it was a good week for those seeking to expand treatment options to patients and to increase the communication about those options to clinicians. "
http://www.mmm-online.com/legalregulatory/21st-century-cures-amarin-court-case-advance/article/425992/
A somewhat biased take of the 1st amendment hearing:
"Yesterday, Manhattan District Judge Paul Engelmayer asked some very probing – and some very naive questions regarding Amarin’s request for a preliminary injunction allowing it to tell doctors about the unapproved use of its Vascepa (icosapent) fish oil pill.
Judge Engelmayer engaged Assistant US Attorney for the Southern District of New York Ellen London, why a truthful, non-misleading statement by itself could be considered “actus reus” – the wrongful act of a crime – to support misbranding. London asserted that statements serve as evidence of intended use and require other elements to be prosecuted as misbranding. Good answer – but not good enough for Judge Engelmayer.
The judge kept asking why the FDA allows a heart disease claim for dietary supplements with EPA but does not permit it for Vascepa. His Honor needs a primer on DSHEA – and the FDA had better be prepared to offer it, otherwise this misunderstanding will persist – to the detriment of the agency’s case.
The Judge also questioned London about when the agency would be issuing further guidance on off-label communication, asking if it would be in 2015 or afterwards, or before Labor Day. Ms. London said she has “no idea” when the agency would act or if more speech will be permitted when it does. That looks like a signal that the court wants to grant the agency chevron deference – but not minus a written guidance.
According to Judge Engelmayer, there were “terrific arguments on both sides,” And closed the hearing without making a decision.
Note to FDA, “An ounce of action is worth a ton of theory.” (Friedrich Engels)
- See more at: http://drugwonks.com/blog/for-fda-and-amarin-
terrific-is-in-the-eyes-of-the-beholder#sthash.6K3dBnBo.dpuf
http://drugwonks.com/blog/for-fda-and-amarin-terrific-is-in-the-eyes-of-the-beholder
Rose, statin treated patients are estimated to generate an annual event rate of 5.2-5.9%. Do you think statin is such a magic potion that you can't reduce the event rate further with 4g/day pure EPA?
My best JL imitation was a failure. Thanks to the real JL for the rescue.
HD, can't get anything pass you. I also detect a tone down in level of optimism from Q4 to Q1 CC.
HD, do you agree the fact that John Thero sounds very optimistic during CC by mentioning interim readout repeatedly and his ability to get Baker Brothers involved in Amarin means his internal estimate of Vascepa MACE reduction % is tracking satisfactorily?
Last question, JL mentioned one crude way of estimating Vascepa MACE reduction % is:
1) calculate the MACE reduction % based on event rate occurred up till May 2013 (before full Vascepa effects kick in and the TG requirement increase), call that worst case placebo rate, for example, 5%.
2) calculate the MACE reduction % based on event rate occurred from June 2013 to the current date, call that the composite rate, for example, 4%.
3) Vascepa MACE risk reduction rate would then be estimated to be 40%.
Any feedback on such an estimation method?
HD, do you think John Thero and Steve Ketchum have an estimate of Vascepa MACE risk reduction % based on what they know of R-IT event number to date?
Vascepa is listed as Tier 2 while Lovaza is listed as Tier 3. See p.10 of the link,
https://www.umr.com/oss/cms/UMR/DignityHealth/dignityhealthdocuments/PDL_LegacyInnoviant_ORX6700D-INV_150101.pdf
Optum is the in-house PBM (Pharmacy Benefit Manager) of UHC.
What Americans expect FDA to do on drug approval is apply risk/benefit analysis. FDA admits in court that Vascepa is very safe, i.e., risk is very low. Unless FDA can come out with proof now that Vascepa has zero benefit in preventing CVD, ANCHOR indication should be approved ASAP.
I gladly take 10 cents for a rumor. It's only fair given we drop 15 cents for a BS Watson NCE appeal request.
"government admits that there is evidence supporting a correlation between high triglycerides and the risk of cardiovascular disease," Vascepa meets all endpoints in reducing trig in ANCHOR trial. Why Attorney London lied to the court that Vascepa is not safe because it's not efficacious?
Thanks. I know I can count on you MrMain.
Wondering if high TG is highly correlated with low HD, not just within the diabetic community? If so, then your worry of R-IT having too many normal HDL patients should not be a concern. I don't even know if R-IT patients were allowed to take any HDL medications.
Ajax, no worry. You are good in my book. I guess I am just still puzzled why FDA was willing to compromise and negotiate with John Thero over MLK weekend several years ago but unwilling to give in a bit after all these years. Have a great rest of the day.
Math quiz:
Avg. TG = 150
Minimum TG = 150
No. of samples = 2000
What's the maximum TG level among the samples?
HD, where you see that suggest "decrease in TG does not decrease the incidence of heart attack"? That seems to contradict with the genetic studies result on p.9 of the June 1st slides. Furthermore, Amarin increased the TG requirement from 150 to 200 in May 2013 because MACE was tracking below expectation. MACE were then starting to track expectation after the raised TG requirement, according to company management.
AMRN stock gaped down over 10 cents @ open and close breakeven is encouraging, with biotech index down 1.48%
Kiwi, hope all is well with you. Please see p.5 and p.9 of the June 1st Amarin slides,
http://files.shareholder.com/downloads/AMRN/3172500589x0x799267/B882FB49-4910-4F4D-9534-301ED99C78ED/Amarin_Investor_Presentation_Jun_2015.pdf
Ajax,your statement "the first 2000 patients
enrolled, had Trigs on average of 150mg/dl." is not true. Please re-check your fact.
North, you made a great point. Thanks.
Thanks Ajax for no CAPITAL LETTERS in your post, much easier on the eyes.
How so? Vascepa's DES claim is not "truthful and non-misleading" since there's no FDA sponsored trial to prove its efficacy on DES.
Freak, I thought you sold your shares and had moved on. What Happen?
"when was the last time "perfect world" and "AMRM" were uttered in the same sentence". Why you still dream about multi-billion M&A now?
If AGN/TEVA/Watson were indeed interested in Vascepa for DES, they would try to steal it from Amarin first like in the NCE situation.
Also before share dilution and $150M high interest loan.
Thanks JL, I re-read Amarin's June 1st presentation (see link),
on p.5 it says no benefit for subgroup of low HDL for both AIM-HIGH and ACCORD while benefit for subgroup of high TG & low HDL. That further confirms with multiple genetic studies results on p.9. That argues Vs Kiwi's thesis of enrolling patients with low HDL is better for R-IT trial success.
http://files.shareholder.com/downloads/AMRN/3172500589x0x799267/B882FB49-4910-4F4D-9534-301ED99C78ED/Amarin_Investor_Presentation_Jun_2015.pdf
Watson is pissed because it might lose its first filer advantage. Watson has nothing to lose by filing an appeal. If I were you, I won't speculate on any potential M&A about AMRN. It's not productive for you and this message board.
Thanks James for your reply.
Amarin v. FDA and Public Meeting On Off-Label Promotion Signal An Important Year For Clarity Around Scientific Exchange and the First Amendment,
http://www.policymed.com/2015/05/amarin-v-fda-off-label-first-amendment.html