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In Reply to
'BioChica'
"B.S."
Ummm... OK. As long as you are sure you know what you are talking about.
Unnh...
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM410139.pdf
Sometime in the last coupla three four years, an intrim look was released to a company's upper management and it got to the sales staff. Who did what salesmen always do. There was hell to pay and the FDA released an official communication about interim data on subsequent studies. Anybody out there flesh this out for me?
The 30-90 days is the time FDA needs to revue and classify this info, then work through the regulations. I would not be surprised (or disappointed) to see a request for another sixty days at the end of Oct.
Again, no issue here. but we live in a world of mostly non Amarinites. Don't think the market as a whole will not see this and think, "Easy short term short " on the news."
That's when we lever up...
What is your point? Obviously the later the 967th comes the better the efficacy. Just not sure what you're trying to say.
That given a slope of events vs time, you prolly get a linear relationship after time and numbers work long enough. But the closer to the beginning of the study you get, the more the actual plot looks like a funnel with an envelope of events with greater variation about the ultimate rate expressed by a straight line. The earlier the look, the greater the likelihood that the data can look especially good or especially bad depending on luck of the draw, dropouts of the P group, natural variation etc.
As much as we are sure enough to bet on a good ultimate outcome, an early stop is the reward for the beating we've taken. Our luck has not been something I'm comfortable betting on. The later the interim, the more events in the P group, the less I'm concerned about effect of traffic accidents, drop outs, the luck in the allocation to one group or the other, etc...
The pocket calculator(now phone) was one of the worst things ever to happen to off the cuff analysis. Percentage is automatically calulated to 4 places. The calculator is accurate , still....
The Reduce It study has been ongoing for 45(?)months. We're waiting on the 960 eth plus event. Do the math (I'm lazy) of adding or reducing the events by an average of one event a month. After all, these are people and not simple chemical reactions in a beaker. Varience, ya know. See how it affects the time to trigger the look. Granting that the study will either under or over estimate V's effect, I'd rather wait until mid/late summer 2016 for THE LOOK. It might be the varience of an exceptionally healthy placebo group or exceptionally effect V driving the look into the future. I'm more comfortable with that, than the 967th tomorrow if it's driven by a bad varience in the V group that continues the study and we have to wait until late 2017 to have it corrected by numbers and time.
Outa my hands anyway...
"Out of curiosity and boredom...
For those bold enough to say, what percentage of your portfolio is in AMRN?"
Do include the 100 shares I always buy AH at .25 over close?
Or just what I had at close?
??? Why the immediate need for Reduce It Interim data. I want 100% efficacy and another year until it is triggered by events.
Think of the ANCHOR label as allowing the permissable off label selling to the Reduce It population. Kinda like MARINE approval and completed ANCHOR allows pre approval off label to the ANCHOR population. The ANCHOR label would justify a ramp up on production and sales which would be in place on Reduce It completion. Or the whole thing collapses. My bet is already placed and the dice are rolling. Stayin' busy onna boards while the dice roll and roll and roll.....
Nah. The legendary 100 shares AH up .10 buyer drew a buncha speculators buying 100 shares ahead of him, sure that they could sell to him @ 2.55. Sure enough....
Just catching up, but it is pretty obvious in hindsight that yesterday's conference presentation was the template for off label promotion. Every valid point was hit, the evidence was marshalled, and that was why it was so concise and ticked off all the studies.
For way too long, long time holders have been looking for everything that appeared on the horizon to be the rescue boat. Instead, yesterday the waters started to recede.
You can ALWAYS sue. The issue is whether the law suit will benefit the plaintiff or the lawyers.
My only position is that it be part of an time, resource and cost effective strategy.
Who bought @ 2.54?
Someone who will be a patient holder to eventually fix a fat finger trade. Prolly. I've been on the other side; someone took a flier pre earnings on something that spiked in the last 5 min and that I wanted to get out of and listed for an ask of Last plus .50 cents. Unexpected trade, but one side happy and the other side miserable the next morning... Beware after hour at the market trades. The last 300 shares on Level Two might be listed @ $1000 Ask....
Anybody got a worst case/post smoking wreckage/save something case for AMRN post failed Reduce It on the basis of Marine 1st A quasi Anchor?
Not wrong.... Just different cost (time) / benefit analysis by each of the parties...
Yup, we are just talking about rustling under the covers. That were formerly shrouds. Still.... makes for a nicer weekend... even if there is an agree to disagree letter, it shows where both parties think action will be... and AMRN can market all the way, crying WEEEE WEEEE WEEEE
1st A news will be hard to figure/predict. The gov has deep pockets (our money). FDA does not care to lose. Inclined to take everything to the limit. US attny is on salary, Has to do SOMETHING all day. Private attorney would take the client's money. $'s take sting out of loss. But gov attny's live by their rep. They do not not care to lose either. But case is a losing case. Preliminary (got a buddy who's a big time business law attny) action says, "Don't make me sit through this. We KNOW where this is going. You guys figure this out." Stakes are huge for AMRN, steep for FDA in terms of precedent and eroding authority. Number of clear paths. And a lot of conflicting incentives. My bet is agree to disagree and a trial. Ands that is not bad for AMRN. They can continue to sell and the path gets steeper for the FDA.
See ya at the REDUCE IT partee in 'Vegas....
The neat thing about limit orders is that if they miss you onna way down, they can catch you on the way back up... If you had a stop at 1.8, if you didn't clear it, you got cleaned out on the way back up...
As unacceptable as clearing every bit of promotion with the FDA is the FDA allowing ANCHOR and mooting the whole 9 yards. There is a lot of space between the two positions. Monday meeting and Friday letter to the judge. i'd like to buy a ticket to watch this.....
It's a serious down trending momo market, AMRN is trending down also, and it is getting to a whole, very significant number in terms of stops. Prolly one last thrust below $2 today and an attempted gap down below 1.90 tomorrow. Totally expected and absolutely eyewatering regardless.
Judges have a case load and like most of the rest of us, the lighter and more interesting the work, the better. The initial filing and the PI portion of the case has previewed the main case. If the judge finds that one side of the case is particularly weak, he may not wish to sit through an easily predictable procedure to get to where he expects to get to anyway. The question at hand is whether Amarin's getting pretty much what they asked for in the PI w/ some minor embelishments sends a message about where the case is heading and that he expects that the FDA should settle and not waste further resources. Is the 28th a courtesy call to find common ground or a last chance to bow out and save time, money and define the loss and limit the risk of further significant loss?
The downside of not settling is the risk that the the first couple of paragraphs of the eventual decision implies that "the FDA was given every chance to avoid getting here and now... "
Can someone explain how company operations are significantly impacted by whether or not NCE is posted now or a month later? Or share price? Withdrawal/statis of generic applications is a much bigger deal. The degree without the diploma.
I'm already on record as complaining about how last Thursday's news is not reflected in last week's scripts due out tomorrow. Getting it out of the way in case I sleep late.
Still waiting on prescription increased results of revised marketing and ultimately, Reduce It.