It is a dose dependent result and you are just on the high side with your TGs. Realistically, you will still probably need to take 2 grams daily. After 2 months, get labs done to see where you are, maybe you can drop to 1 gram maintenance, I just wouldn't necessarily count on that.
Hey "chop sticks", what's wrong with a little harassment anyway? I might suggest that it would be fun to see your head cracked open like a coconut on the beach. You might call that harassment, I'd call it entertainment! Get lost A-Whole!
I went over to the organized groups on iHub who've developed a web page for All-things-Amarin-and-Vascepa and queried whether a single point for all contact lists could be established.....waiting for response. The new site is: epadruginitiativedotcom.
Perhaps that block of Chocolate you ate earlier today was in fact a block of Hashish from Afghanistan and you've begun manifesting delusional paroxysms. A buyout price of $3.50 would not even be worth publicizing. This company can not be sold for anything less than $10.00/shr and that would be almost free for BP. IMHO
gr8, this SPA, as accepted by the FDA, was for Anchor and had absolutely nothing to do with Reduce-It! It only required that Reduce-It be substantially underway before Amarin could submit label expansion for Anchor Trial.
AK, that's all great but I haven't seen a partner come forward yet. As I said, the company should try all possible avenues to remain viable and when a partner signs on the bottom line, full speed ahead with Reduce-It. But without Anchor, the company is in peril and that's where I draw the line. No Anchor, no Reduce-It plays much better for me than NO CAPITAL, NO AMARIN. That is business!
I have no real objection to maintaining the status quo on Reduce-It until the December PDUFA or until a Letter of Rejection is received from the FDA. But if the Anchor indication is not approved as agreed by the FDA, then Reduce-It MUST BE CLINICALLY SUSPENDED. I've heard many argue the moral necessity of Amarin continuing the trial, that the knowledge to be gained is more important than the difficulties Amarin may need to face in the short term. To those I say,,,,,,,,has someone here mistaken me for Mother Theresa?
Amarin is a business that I invested in, it is not the American Heart Association. We have a great drug on the market TODAY with sales growing weekly. ALL of the company's resources, financial and otherwise, need to be devoted to furthering the continued success of that product. Reduce-It needs to be put on a back burner until the survival and success of Amarin is guaranteed, understand? If that involves deal-making or partnering with BP or whatever else management conjures up, then so be it. But the first move to save $40 million per year is to suspend R-It.
Leave the altruism to the Melissa Gates and Warren Buffets in the world, they can afford it. They don't have to deal with the FDA! There is an SPA Contract in force and it is POSSIBLE that the Agency may renege on it, an action that could drive Amarin into bankruptcy. This entire ruinous situation is on the FDA and if it fails to negotiate some kind of compromise approval with Amarin and heeds the vote of the AdComm Panel instead, then the company goes into survival mode....NO OTHER CHOICE. And if the Reduce-It Trial can be reinstated down the road, I'll be all in favor THEN!.
Right back to you, morgan! Hope the wind blows gently for you this weekend. Stay healthy!
I wish it weren't true but damn-it you were right on target and one of the first to flash a Warning Sign !! Unfortunately I didn't heed your advice and got slammed like so many others......but I won't forget your words in the future, particularly WRT the stinkin' FDA......rat bashtuds! Stay well Kutz. .
Take a look at the post above this discussing FDA Regulations and sNDA. Maybe something to it. BTW, I'm in the same boat with you only mine were Oct, (200 Calls), Nov. (300 Calls) and Jan. (100 Calls) + 20K shs. Good luck to you both.
I checked both of my trading platforms and couldn't find any trade. Where did you verify this trade activity?
After reading your DD concerning retraction of sNDA by FDA, I forwarded your findings along with my thoughts regarding failure by the FDA to follow their own published protocol and included the question, "Can you use this to negotiate with the FDA?" No response yet.
I'd be really pleased if this was true but I'm afraid no such trade occurred. Good Luck to you!
In fact, they may not have cover.....they were supposed to follow a specific protocol if it was their intention to introduce "new science" as a reason for recalling the sNDA. The protocol was not followed.......a fact identified by BioBill (iHub) / Williams (Yahoo). Something is rotten in the District of Columbia.
Have a look at this Study:
AMSTERDAM – People with congenitally reduced triglyceride levels had about a 20% reduced risk of all-cause death compared with people without inherently low triglyceride levels during more than 30-years follow-up of nearly 14,000 people enrolled in the Copenhagen City Heart Study.
Data from the study also showed that people with higher triglyceride (TG) levels at the time they entered the study had significantly higher all-cause mortality during more than 30 years of follow-up than did people who entered with lower TG levels, Dr. Børge G. Nordestgaard said at the European Society of Cardiology annual congress.
But the result from the genetic analysis provided even more persuasive evidence that it is time to run a large, prospective intervention trial aimed at testing the preventive efficacy of TG lowering in patients selected based on elevated TGs, he said.
The genetic analysis "took advantage of nature’s randomized trial," said Dr. Nordestgaard, professor and chief of clinical biochemistry at Copenhagen University Hospital. The genetic analysis looked at long-term survival relative to the number of TG-lowering alleles each person had in their lipoprotein lipase genes. "These data suggest a causal relationship between low TGs and improved survival. Lots of drugs are available to lower triglycerides, such as atorvastatin and rosuvastatin, but so far all the trials only focused on high LDL or low HDL cholesterol. No trial enrolled patients on the basis of high triglycerides.
"A lot of people have normal LDL levels and high TGs, and right now they are ignored," he said. "Before statins, everyone talked about high LDL and high TGs as being equal risk factors, but now TGs are completely forgotten. A big mistake has been interpreting results from the statin trials, because the participants in those studies did not enter the trials because of their TG levels." (PULLING MY HAIR OUT!!)
Dr. Nordestgaard and his associates performed