"The whole deal is worth much more"
Or, if they don't defeat Parkinsons, a lot less. The potential $600M milestone payments will only be paid in full in the event the drug succeeds in phase 1, phase 2 and phase 3 trials and is them commercialized. That's not exactly a given now is it? How would you discount the future value of this potential cash flow? Realistically the current value there is likely around 12 to 15% at best, given drug failure rates and could be worse here given that nobody has ever found anything effective against this disease.
A Skeptical Look at Dwight Lundell, M.D.
Stephen Barrett, M.D.
Dwight C. Lundell, M.D. lost medical license in 2008. Since that time he has been promoting books that clash with established scientific knowledge of heart disease prevention and treatment. His book, The Great Cholesterol Lie, invites people to "forget about everything you have been told about low-fat diets, saturated fats, cholesterol and the causes of heart disease." According to The Great Cholesterol Lie Web site:
Dropping your cholesterol levels will not lower your risk of heart disease, attack, or strokes.
During his career as a cardiac surgeon, he performed over 5,000 heart operations, most of which could have been easily prevented had the patients been given the right information.
"Heart disease has a cure . . . .You can beat it without harmful medications and painful, risky surgery."
The Great Cholesterol Lie . . . is "as close to a new heart as you can get without laying on Dr. Lundell's table."
Lundell "guarantees" that the book "can turn your health around."
Google "A Skeptical Look at Dwight Lundell, M.D."
What, stop awarding performance pay until there's performance? Are you insane? What if there's never performance? Are you suggesting management's pay should be related to performance?
It looks like the FDA is opting for the slow death approach. In not allowing the appeal to a fairly obviously flawed decision in rescinding the SPA and not updating Amarin on the process, the FDA is dragging out the procedure. Another month has passed with no progress and Amarin's critical cash is running out. All the FDA needs to do is prevent any movement forward until Amarin runs out of air and dies.
Amarin's best option, under these circumstance, is to go the legal route immediately while it has enough funds to do it. What the FDA has done is illegal and needs to go before a court if Amarin is to get any relief. The FDA will never admit this blunder.
Seem to be saying Reduce-It cannot continue without the revs from the Anchor indication. Is it possible the FDA did not know this?
Enrollment for the REDUCE-IT outcomes trial of Vascepa continues at over 450 sites spanning 11 countries. In Q3 of this year enrollment for the REDUCE-IT trial surpassed 6,000 patients. As previously reported, the mean and median baseline triglyceride levels for patients participating to date in the REDUCE-IT cardiovascular outcomes study has been confirmed to be 200 mg/dL. As intended, these are higher baseline TG levels than levels studied in other recent outcomes trials of other lipid modifying therapies. Results of the REDUCE-IT study will not be available until a specified number of cardiovascular events have been observed. Based on current expectations, unless feedback from pending discussion with the FDA regarding the ANCHOR sNDA results in modification or termination of the REDUCE-IT study, results of this blinded study are anticipated in 2017. Amarin estimates that over $100 million is required to complete this study. While Amarin remains scientifically committed to continuing the REDUCE-IT study, Amarin anticipates that the trial may be difficult to complete without the expected revenues from the previously anticipated ANCHOR indication."
"Commenting on the FDA's recently expressed position that the results from the ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE trials fail to support the hypothesis that a TG-lowering drug significantly reduces the risk for cardiovascular (CV) events among statin-treated patients and that such results constitute a new substantial scientific issue, Steven B. Ketchum, Ph.D., President of Research and Development of Amarin provided, "We intend to continue to work vigorously in support of improved patient care and labeling of Vascepa for the ANCHOR indication. Toward that end, we have submitted to the FDA all materials needed to appeal the FDA rescission of the ANCHOR Special Protocol Assessment, or SPA, agreement and have begun the formal appeal process with FDA. We believe that had the FDA advisory committee been asked to vote on the indication supported by the SPA agreement for ANCHOR and by the ANCHOR results submitted in our sNDA, the outcome would have favored Vascepa approval." Amarin plans on today's conference call to further discuss this appeal and Amarin's perspective on why the ANCHOR indication should be approved."
"The Food and Drug Administration on Thursday proposed measures that would all but eliminate artificial trans fats, the artery clogging substance that is a major contributor to heart disease in the United States, from the food supply:- "Under the proposal, which is open for public comment for 60 days, the agency would declare that partially hydrogenated oils, the source of trans fats, were no longer “generally recognized as safe,” a legal category that permits the use of salt and caffeine, for example."
Apparently products that increase LDL-C should be banned but products like Vascepa, which lower LDL-C,
should not be allowed on the market because there's no proof Vascepa reduces CV events.
"Dr. Margaret A. Hamburg, the agency’s commissioner, said the rules could prevent 20,000 heart attacks and 7,000 deaths from heart disease each year."
What the heck is going on here?????? Does the FDA not know what it believes?
"Thirty-three studies reported data on CVDs mortality; together recording 17,018 CVDs deaths in 726,030
participants; and 38 studies reported data on all-cause mortality, together recording 58,419 deaths in 330,566 participants."
"In conclusion, elevated blood TG levels were dose-dependently associated with a greater risk
of both CVDs and all-cause mortality. The findings of this meta-analysis suggest that
controlling TG can help to prevent CVDs and other causes of death. "
I'm not sure what's going on at the FDA but they can't possibly continue to ignore the data. The linkage between high blood trig levels and CVD is well established.
Amarin has no value in the the event Reduce-It continues. There's no possible way to finance such an huge trial now without wiping out current common.
Look on the bright side. It's only a 50% dilution on this one. Next dilution likely next year. The money raised usually winds up paying management to achieve the fantastic results they demonstrate year after year!
As any long term long will tell you, you can buy shares now or wait 'till next year and get twice the number for the same price.