Shareholders will continue to suffer not management. In fact management is doing just fine with all the shares they sold last year @ $14. Low SP will be their excuse for not selling the company (if there are any potential buyers at all). They would rather dilute and keep milking the company just like they've done for years. Just look at a chart. The PPS went down from $1400 to $1.4 for a reason.
If you have big hopes for Dec 20th, you are setting yourself up for another disappointment. I watched the whole Adcom thing. It's crystal clear FDA doesn't want to approve label expansion.
And JZ mumbling at a conference call wasn't a big help either. No plan "B", no partner. Nothing.
At some point I thought I'm getting a steal at $8, now I wouldn't be surprise if AMRN dives under $1.
According to JZ with a partner Amarin will be getting only 30-35% of the revenue. BO is not very likely either as FDA was very cautious yesterday pretty much on everything including upcoming Reduce-it results. Even if the results are favorable in 2016 (after several dilutions) FDA might still question them because of the stupid Mineral Oil placebo issue.
I hope they announce either partnership or sale of the company if they don't get positive vote on Wednesday.
FDA panel should consider a bigger picture reviewing Vascepa, not only potential CV benefits.
- Very high triglycerides can cause swelling of the pancreas. This causes severe belly pain, vomiting, and fever. If digestive juices leak outside the pancreas, it can be life-threatening.
- Very high triglycerides increase the risk of type 2 diabetes. High triglycerides are part of a condition called metabolic syndrome, which includes high blood pressure, increased belly fat, low HDL (good cholesterol), and high fasting blood sugar. Combined, high triglycerides plus any two of the other conditions, increase the risk of developing type 2 diabetes by five times.
- Having high triglycerides and two other metabolic syndrome conditions doubles the risk for heart disease. Young adults with very high triglycerides have a risk of heart disease that is four times higher than those with slightly elevated triglycerides.
- Triglycerides affect the blood vessels that supply your brain. A recent study found that for older women, high levels of triglycerides are the number one risk factor for stroke.
- Fat accumulating in the liver is the most common cause of chronic liver disease. This can lead to permanent scarring of your liver, cancer, and liver failure, which is life threatening. In non-alcoholic fatty liver disease (NAFLD) more than 10 percent of the liver has been replaced by fat. The most common causes for NAFLD are diabetes, obesity, and high triglycerides.
- Too much fat in the blood causes deposits to form in the arteries that flow to the legs, which could lead to peripheral artery disease (PAD). PAD can cause pain and numbness in the legs, especially when walking. It also increases the risk of infection in the legs or feet. Metabolic syndrome, including high triglycerides, is one major risk factor for PAD.
- Research is showing that high triglycerides may damage blood vessels inside the brain and contribute to the build-up of a toxic protein called amyloi.
Sentiment: Strong Buy
SPA allowed Amarin to submit Anchor application, but it doesn't mean FDA has to approve it. That's how I see it.
I really hope Amarin is ready for Wednesday. We need a solid vote.
Even FDA admitted that TG and other lipid parameters increase probably wasn't due to mineral oil use in the placebo group as similar increases were observed in Lovaza clinical trials that didn't use mineral oil.
So if not mineral oil as FDA suspects what else it might be? I hope Amarin is ready to answer this question on Wednesday.
"During the review of the MARINE data, the Division noted that several lipid parameters
(including TG) increased from baseline to week 12 in the placebo group, treated with mineral oil.
The available literature regarding potential effects of mineral oil was considered. Similar
increases in TG levels observed in the placebo groups from the Lovaza (omega-3 EE) clinical
trials of hypertriglyceridemic patients were noted, and these trials did not use a mineral oil Page 12 of 94
placebo. Because no strong evidence for biological activity of mineral oil was identified,
ultimately it was concluded that the between-group differences likely provided the most
appropriate descriptions of the treatment effect of AMR101 and that whatever factor(s) led to the
within-group changes over time in the placebo group were likely randomly distributed to all
treatment groups. Taken together, along with the statistical robustness in primary and sensitivity
analyses of AMR101 4g/day on TG lowering, the Division concluded that AMR101 4g/day is an
effective TG-lowering agent for patients with severe hypertriglyceridemia. AMR101 was
approved for the following treatment indication on July 26, 2012"
Do yourself a favor research Jelis study. 19% relative reduction in major coronary events.
Sentiment: Strong Buy