Very good analogy. Would you rather drink your H2O from the salt water Atlantic Ocean or from a purified water filter. Thanks for the post!
Anyone know how Vascepa compares to some of its competitors regarding CV related markers? There's the obvious comparison between V and Lovaza regading LDL-C. However as we move toward the belief that inflammation is a key contributor of CVE's and RI hopes to demonstrate efficacy 20%, there hasn't been much published. Part of this is probably because L, Epanova and others have not yet conducted a CV outcomes study.
I asked the OTC fish oil advocates on this board to provide clinical studies but no one has been able to step to the plate to date with even a small scale study they discuss.
What is your basis for $4? Failed RI outcome? What's your efficacy estimate for RI interim in 2016? Please provide a legitimate response.
Over the last 2 months, 8 analysts covering AMRN have modified their 2015 EPS estimates from -29 cents to -35 cents. This is roughly $10.5 million change. Is this due to GM change in their models?
I made $300,000 in DNDN when i sold in late April 2010! Can't help today's share price. So the bottom line is this and I'll ask this one last time: what clinical benefit does OTC fish oil have on inflammatory biomarkers? No one has provided a link to support their argument - end of story.
What?????????????? "flood the market uncontrollably???????? You have to be kidding me. The Anchor sNDA was denied because the FDA decided to move the goal posts. They made a loose connection between Anchor and the failed niacin studies and decided that achieving/exceeding endpoints was no longer important. They became focused on reducing CVE's and decided to wait for RI completion.
I don't think so. We've seen the patent stable grow over the the couple of years w/o PPS change. Likewise, I don't see scripts moving the price a whole lot either. What we need are some of these so-called catalysts to occur.
- NCE status which would have a low impact on PPS growth
- sNDA resolution which would have a moderate impact on PPS growth (if positive)
- funding to RI w/o debt or equity changing the capital structure of company which would have a moderate impact on PPS
- patent/launch resolution with AZN Omthera which would have a low impact on PPS
- continued positive science news which would have a low impact on PPS
If we get clarity on these issues in 2015 - as well as others - then we'll see a MAJOR rally. As this point, strong scripts are just a part of the operational "blocking and tackling.
There are a couple of OTC fish oil advocates using several alias's comparing OTC products to Vascepa. No one has provided evidence of the benefit of theses products. My question is not directed at "systematic review of literature" or "national library of health". My question relates to the quantifiable benefit of using OTC fish oil products in its ability to lower key cardiovascular biomarkers. Can you demonstrate or provide clinical evidence that supports OTC products having lowered APO A, Lp-PLA2 or shown a statistical benefit? Matt Herper may provide a starting point point.
There you have it!!!!!!!! A logical explanation that is straightforward and concise. I would like to thank you for your contribution.
Sentiment: Strong Buy
I am awaiting your response regarding clinical trials or scientific evidence regarding your position on OTC EPA. You have a short posting history (3-4 posts), however you are others supporting your position continue to make claims regarding efficacy similar to Vascepa. You have an opportunity to put up or shut up. Where's your evidence or documentation?
Totally avoided the question. What you described can simply be found on the label. What I'm asking is "CLINICAL" studies of OTC EPA that validates clinical endpoints such as those I described - again - APO A, Lp-PLA2, VLDL or HS-CRP (although HS usually indicates general inflammation).
On a related note, you probably shouldn't be investing in stocks when it appears you're unable to comprehend, assiminate or digest information.
There has been too much evidence in recent months for the FDA to ignore in the Anchor sNDA application. Whether it's full label expansion (200-400 market) or simply a labeling issue, the FDA is now in a corner with this decision. Everyone is aware their decision to shelve Anchor was based on their position of "both endpoints" and the past results of somewhat unrelated studies involving niacin (AIM-HIGH & HPS2-THRIVE). If the FDA utilized these older niacin studies to support their Oct. 2012 decision, then the recent IMPROVE-IT study, remnant like particle analysis, Lp-PLA2 announcement as well as recent documentation supporting EPA have to be included for this agency to avoid looking like fools. As we draw closer to event 967 there will be continued momentum supporting supporting both Reduce IT and Anchor. It is interesting to note the ongoing FDA sNDA delay. You have to wonder if this issue is currently involved in discussion at a higher level within the agency.
Could anyone tell me the clinical effect these dietary supplements have on cardiovascular bio markers such as APO A/B/C, Lp-PLA2, or VLDL, just to name a few???????????????
I was looking at slide #18 from the investor presentation. The Jelis subgroup (n=945) showed the divergence around year 2.5. As I recall, this was 1.8/gr. daily with trigs 150 and HDL