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The trial goes on. The FDA could use an early stoppage to again sabotage AMRN.
I think it is really harmful and not a good thing that the expectations for an early stoppage have gotten so high. The company has major blame for this. Anyone who thinks this trial will be stopped early is just setting themselves up for a huge major letdown. The expectations for an early stoppage should have NEVER reached the current level and it should be viewed as a highly unlikely event, which it is a highly unlikely event. Instead people are now seriously expecting it to happen, and that is a detrimental mindset.
I also think a real possibility for this trial is that while death rate might not be that different, perhaps time to death might be different. I could see Vascepa helping to stave off death for a little while, but ultimately not being able to actually save the lives of these sick people outright. Those goes hand in hand with time needed to show death differences. I also think this could be a possible outcome with event rates. Perhaps the number of events might not be hugely different, but the time to event could be. Say the control arm has an event happening on average 1 year into the trial, while the Vascepa arm is 2 years. Some outcome like that. So while that would be an event in both arms, Vascepa is delaying the event.
This trial has sick people, there is only so much Vascepa can do. It may be too late for many of these patients.
I have brought up how I think the results of this trial may not be black and white. What if event rate is only 10% different, but time to event is 1-1.5 year longer with Vascepa. Is the trial a success in that scenario?
I would think so. But I think for that arm separation, a lot more time would be needed. Deaths need time to materialize and Vascepa would need time to make a difference. The longer the trial goes, I would think the results would get better. Another reason it is better to go to completion.
I think it will only be stopped if the deaths in each arm are statistically different. And that is a lot more sketchy than just event rate. I also think AMRN is better off long term if it isn't stopped. They will be better off with the FDA, and science will benefit from a full study. I do not think the DMC will recommend stoppage unless death rate is statistically different. There is no ethical concerns about letting it go on if just event rate is different but not death rate. People signed up for the trial and knew there was a 50% chance they would get Vascepa. The point of clinical trials is that half get the drug, half don't. Just the way it is. Also, this is not a cancer trial, which are stopped early much much more frequently. The trial stopped today was a cancer trial.
No? Just a technical glitch or it's down while they perform maintenance or something.
Confirmed. But no drugs are showing up.
Exactly. NCE is now irrelevant and will never move this stock.
That is fine if you just wanna bunker down for a little over 2 years and say "I don't care about the stock right now!". That is fine. But that is a long long way away for Wall Street and AMRN's cash position now below $100m is going to have a big affect on the stock price. There is no possible way they will ever make it to REDUCE-IT results without major financing. So if you are just laser focused on REDUCE-IT and believe it will show a great benefit, then more power to ya....these matters such as the stock price and financing don't matter to you. Why even post right now if you have that mindset? We shouldn't hear from you for a couple of years.
But for those of us who take a different view and actually do care about the stock price, management credibility, what price the dilution occurs at, perhaps trying to make some money BEFORE the binary event of all binary events, etc., the current situation matters.
No one knows if REDUCE-IT will work. It might. It might not. Right now the market isn't focused much on that, it is focused on the current situation. And with cash getting dangerously low and scripts not going anywhere (not to mention NCE is now irrelevant), it isn't a pretty situation. More pressing things are on the mind of investors than REDUCE-IT in 2 years! And management has shown time and time again they are pathetic at producing any news of actual REAL VALUE.
Your post made a claim that AMRN was perfectly happy as scripts were benefiting from 1A. All I am doing is saying that so far, 1A has provided no benefit to scripts. And yes, their sales force is small and pathetic. I have said that for a long time that that is the major reason scripts will NEVER grow to significant levels and why they should have at least partnered eons ago. Scripts would be A LOT higher if they had taken proper steps. Also, this small sales force is a reason back when 1A happened I made the claim that AMRN was in no position to take advantage of it. So far, that has played out. Meanwhile I was attacked and ensured by Raf that scripts would definitely double within 6 months. And so far they aren't even anywhere near close to that type of growth. I was also told that 1A would allow AMRN to grow scripts so they wouldn't have to dilute. That is now a pipe dream.
Month after month people keep claiming that scripts are all the sudden gonna take off one day. And the months (and years) continue to pass with slow slow growth.
But again, I am just "bashing". Despite everything I said coming to fruition and being correct. Being right doesn't matter, apparently all that matters if that people pump, truth doesn't matter.
You obviously don't understand what I am saying. 1A has not changed the growth trajectory (neither did Kowa). I trust that this shouldn't have to be explained in further detail.
Except that so far 1A has contributed nothing to script growth.
Don't kid yourself, no one should be surprised if NCE is again denied for some new rationale.
I think you are wrong and there is a delay, for various reasons. But probably pointless to try to explain it to you. But I would think there would also be for the investigator to determine if an actual event has happened. I believe events must follow certain guidelines so it may happen often that an event MAY have happened, and someone may have to investigate to determine if it did actually qualify as an event. And these Drs are busy people and might have the time to do that immediately on demand whenever it is needed. This could contribute to delays of reporting of events.
Real life doesn't move at on demand pace. To not expect at least a few week delay between event and reporting of event is naive and presents an idealistic reality.
There is a delay between when events happen and when they might be reported. This may vary from site to site, or country to country. How long we do not know but it could be weeks to even a couple of months. Also dropout rates are not known. These are big unknowns that greatly affect any simple estimates.
Well, the market says the management that got "NCE" and 1A is worth $1.54 a share currently. So, there's that.
Yes, believe it or not, how good management is affects stock prices. And stock prices affect buyout prices. And yes, believe it or not, but BP will use that to their advantage to get it as cheap as they can.
The stock move and price after successful REDUCE-IT would be affected, however. Given the current valuation, if REDUCE-IT is a success in 2 years, I doubt the stock price goes anywhere near as high as it should. One of the biggest reasons that a stock trades at a premium or a discount is the quality and credibility of management. You are all "perplexed" as to why AMRN stock is so low, so why would it not be that way after REDUCE-IT? Maybe it goes to $10 instead of the $20 you think it should go to.
This stuff catches up and in the end it will cost YOU money. Lower valuation than it should, results in a lower buyout than it should. See, the price per share actually DOES matter cause it says a lot about what Wall Street thinks of this company and the people who run it. To ignore that valuable information is really really foolish and indicative of a novice, ignorant investor.
Interesting. Considering I have been one of the most correct posters on this board about events and facts. And I have corrected a lot of bad information that has been posted on here. But hey, ignore the person who has probably the best track record on here with regards to predictions and living in reality. I have already won $100 off of Raf, who has posted some of the most ludicrous ideas I've ever heard. You can hitch your wagon to stars like that. Good luck!
My only point, which appears to come off as "short" or whatever, is trying to tone done the rhetoric and expectations to realistic levels. The optimism and pumping is so far off the charts it is out of the universe. So I am trying to be the person to bring that ridiculousness back to ground level. Is REDUCE-IT going to be stopped at interim? Highly unlikely. In fact, it is better for AMRN in the long term that it isn't stopped. So saying that view is "short" is ridiculous. Will it show a benefit in 2017? Perhaps, but also perhaps not. No one knows the answer and a lot of reliance is being put that at the least, the trial is run perfectly with no glitches. The trial is very very risky and any outcome is possible. We should know in a little over 2 years, and before that point, there is no reason for the stock to go up. AMRN is now in the wind of the overall market and will go wherever that goes. The only other hope is for them to dilute already and remove the financial overhang. Then people can move forward with REDUCE-IT expectations. But right now, they are way too low on cash given the need to survive for 2-3 years. It has been a consistent message that has shown over time to be correct as the stock has trended downward for the last 10 months, and now volume has completely evaporated when it should be picking up.
Gee, I wonder. Is board full of staunch retail longs perhaps overly optimistic regarding a stop at interim? How could that ever happen! We all know that staunch retail longs are pragmatic, realistic people!
No...$2.50 hasn't been in the picture since September 2015. It had been bouncing around $2 since that point.
Here is the average closing price per month since April of last year until now. Keep in mind that late March last year saw closes of $2.85 and $2.67:
Jan 2016: $1.60
Dec 2015: $1.92
Nov 2015: $2.01
Oct 2015: $1.96
Sep 2015: $2.29
Aug 2015: $2.17
Jul 2015: $2.34
Jun 2015: $2.42
May 2015: $1.96
Apr 2015: $2.35
That is called a downtrend. The market turmoil did not start until January 2016 so as you can see it the downtrend was already in force before that. Like I said previously, the turmoil just accelerated it.
It is not going to be stopped at interim!!!
And to answer that question, if it is stopped (which is so unlikely I don't believe it is worth considering and relying on), the answer depends. If they don't sell the company and plan to continue on with approval and launch, etc, then yes. They will need to dilute, maybe more than if it isn't stopped. If they plan to immediately sell the company in the short term, then they probably won't have to.
But you are talking about a major marketing effort and sales force expansion under the first scenario, for which they have nowhere near enough money to complete. The only scenario that avoids dilution is interim stop followed by buyout, all in 2016. Otherwise, there just isn't enough anywhere near enough money. They are now under $100m in cash and it's falling every day. Not to speak of the large amount of debt. This is simple math.
Yes, when. Not to mention the dilutions of the past. Remember the $1.50 dilution? Would have been better had that been at $2.50, no? Or do you "not care" about that?
I can't believe people are still fighting that they will need to raise money this year. It is a near certainty to occur. But you don't care about the PPS, when that has a huge affect on any future value down the road. Just do the math on the valuation of $10 a share back in mid-2012 compared to the value of $10 a share now. It is a huge difference.
Who cares? You do realize that the price when they dilute shares matters, right? That it literally effects the value of your shares? And that once those dilutions are locked in, nothing can change the price they were executed at? You are indifferent to being diluted at $1.60 a share as compared to $2.50 a share?
Um..no. Look at the 1 year chart. It has been a downtrend since March of last year. It hasn't been able to hold $2 a share since September of last year. And before that $2.50 was resistance and $2.00 was strenght. Now $2 is a long long way away. In about a month from now the current price will be close to the 52 week low (which was the $1.36 hit last week).
This has been trending down for almost a full year. It was trending down before the recent market turmoil. The recent market turmoil just accelerated it.
The move has been down since March of last year. I look at long term trends. The trend is down, and has been down, for months.
Riigghhhttt. The false claim that institutional ownership is increasing. It isn't.
They already sold. From $2.60+ to $1.60. While all of you were singing the praises of "court victories" and "script growth".
Holy no volume batman.
Interest in this stock has completely evaporated. Nice job management, no interest in buying your stock at $1.60 a share. Exciting 60-90 days ahead?
This board could learn a lot from that list. Many of those jump out noticeably as many people on here have fallen for them. And continue to pump based on several of those.
Bottom line is that AMRN will dilute this year to survive, and in two years we will have REDUCE-IT results. Then the company either goes under or succeeds.
You are still clinging to the settlement being a big deal?! Move on! In two years we will know about REDUCE-IT and things can proceed. Nothing significant is going to come out of the "settlement" talks. And yes, I do believe that language/disclaimers can easily take this long. I have laid out why in previous posts. This is the FDA, you expect things to NOT move extremely slow?!
There is no money. The FDA isn't going to be giving AMRN money. So everyone just needs to seriously stop with the insanity! And they won't be "giving" AMRN anything either. REDUCE-IT shows a statistically significant benefit, the FDA will approve Anchor. That is how it works. It is quite simple. There is nothing "extra" involved.
Even if "damages" were on the table, you say $5b in LOST REVENUE? You are seriously going to try to make a case and prove that AMRN, who in the third year of Marine launch only did $80m, would have had $5b in sales in less than two years after Anchor was approved? You are gonna try to make that case?
ha! $5b settlement. Hilarious.
Back on earth, the issue is getting the stock back to $2 a share and $300m market cap.
If it is tracking to 15-20% efficacy then and that is what they expect at the end, then they surely wouldn't be expecting a stop at interim.
Just more unknowns we don't have the answer to.
And if the placebo rate was accurate, the composite rate is higher with lower efficacy, correct? That is the only point I am making. They are seeing x number of events which are tracking to what they expect based on certain assumptions. If the dropout rate is higher than their assumption, then events should be lower than they are seeing. In order to get a higher number of events (which they are seeing) efficacy would have to be lower to increase the composite event rate. Again, assuming accurate placebo rate and no other issues with mechanics of the trial.
There are a myriad of reasons why events could still be "tracking" to what they expect, but the efficacy isn't what they expect. I am not making a declaration about the trial, just bringing up another potential pitfall. Trying to further emphasize that the simplified calculations you keep throwing out are of little value since there are way too many unknowns out there.
But if the dropout rate is much higher than they expect, then actual efficacy would be lower than they are estimating (assuming accurate placebo rate assumption). That was the point of my original post.
Anndd no one even knows what that means.
Just another potential pitfall. Has dropouts been factored into Raf and HD's simplified calculations? High dropout means lower number of events over time than expected. Smaller population = fewer events.
Yep, another leech to suck stock awards and stock options away. Jut what we need! We already have enough of that going on.
And come the crazy conspiracy theories about a Merck buyout and clearly there are ulterior motives! Yawn. As JL pointed out, this dude likely got canned and now has joined the AMRN gravy train. No conspiracy needed to explain this.