Thank you very much for your valuable contribution. You are right, the minute-to-minute price action is inconsequential. I hope you come back here and post your thoughts on the really relevant questions (in addition to SA). Good luck!
Sue-Happy America. I love my USA-ian friends, but sometimes I feel the U.S. was founded by the Sue Indians.
Do you feel they may reject the trial because of skewed data from the placebo arm?
I give up. You are wrong in more ways than one, but you are the kind of person who is smarter than everyone and will never listen. Bye, I wish you well.
Twopack: Depending on their doctor, insurance, etc, some people cannot get V (especially off-label, and this would definitely be an off-label use). Over-the counter EPA is not FDA-controlled and it may be unsafe to take in large dosages for long periods of time. Read the posts made by Akanz.
This is what happens when you refuse to read past the half-sentence that appeals to you. The real Michelangelo would leave no stone unturned to satisfy his curiosity and get to the bottom of his research topic.
While I like Danbury Dude's comments, I am afraid he is wrong here. The Anchor sNDA was about V on top of a statin from the get-go. Sorry...
Previous week (week of 9/27): Total 5930, New 3094, Refills 2836.
Latest reported (week of 10/4): Total 6255, New and Refills not published yet.
I live in Israel. English is not my native language (it is one of my acquired languages, as is Hebrew and a number of other languages). Near Torino? I have never visited Piemonte, but I have read about it in some of Primo Levi's books.
Off-topic: when in Italy (as a tourist), away from the big cities, I often meet people who cannot speak English. On these occasions, I have to use my very limited Italian. I love it how people don't mind my flaky grammar, on the contrary, they tend to compliment me for my Italian. I guess they appreciate my effort. (I do understand everything, the problem arises when I need to do the talking.)
Thank you very much for taking the time to provide such detailed replies.
Let's hope the FDA follows the logic! (I am afraid I know of a few instances where this was not the case.)
'Tekk, do we know of any specific cases where someone was prosecuted for a #$%$ (manipulative) title and had to eventually pay up?
I am not sure I understand your question. The Anchor sNDA is for a different patient population than Marine. Yes, the FDA knows that V lowers the markers, but on the other hand, they seem to be questioning whether the markers are relevant to outcome. The label is for trigs in a specific range, there is nothing to expand further. Or, are you talking about the Anchor range as an expansion of the Marine range?
"Several cardiovascular outcome trials of non-statin lipid-modulating therapy, such as
those referenced by the Division in 2008, have since completed. ACCORD-Lipid, AIMHIGH,
and HPS2-THRIVE, which were designed to target residual cardiovascular risk
by improving lipid parameters other than LDL-C (e.g., HDL-C and/or TG) in patients
optimally treated with statin therapy, failed to demonstrate unequivocally additional
cardiovascular benefit from non-statin lipid-modulating drugs. Several hypotheses could
be put forward regarding the failures of these large, carefully designed trials to
demonstrate benefit on their primary endpoints, but the evidence to date certainly
challenges the hypothesis that adding lipid-modulating therapies to patients optimally
treated with statins will reduce residual cardiovascular risk. Although it can be argued
that lipid and/or lipoprotein parameters can be used to define subpopulations of statintreated
patients who would be expected to benefit from various non-statin lipidmodulating
agents, contemporary trials have not yet prospectively tested this hypothesis.
Members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC)
are asked to consider the results of the ANCHOR trial in the context of the available
science when recommending whether to approve the proposed treatment indication for 4
grams AMR101 daily to be co-administered with statin therapy for the treatment of
patients with mixed dyslipidemia and coronary heart disease (CHD) or its risk equivalent."