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What are you talking about? I "removed it"? I have no idea what that even means? And the discussion was about whether the DMC has a staff of people working for it. I have no idea what in the world you are talking about.
Please provide information that shows the DMC has a "staff of people" working for them. I would be interested in seeing that. Also curious who would be paying this Staff of People.
Thanks!
A DMC Staff? Um...I highly doubt that exists. Most likely it is AMRN's job to determine when the event has been reached and to notify the DMC for the data review. The DMC does not have people getting paid sitting there refreshing every day to see if the event has happened. The DMC is not an organization, it is a group of medical experts who come together to review the data and make a recommendation.
Doesn't matter if they took them to court if there is zero follow through to complete the objectives they set out to apparently complete. What the hell good is an NCE "court victory" with no NCE? They stopped short in both these cases. That is the issue. And now the market knows 1A is pretty meaningless as scripts have not responded one bit. AMRN sits on CC and tells us their goal is a final judgment yet here we are 7 months later still in these endless "negotiations" over a settlement. 1A should have been very very simple. Are you going to give us a label expansion? The second the FDA said NO or wavered in ambiguity on that answer (basically anything other than a firm YES), it should have been right back to court immediately.
And what boat was rocked? We are 9 months since NCE ruling and still have no exclusivity. We are close to 7 months past 1A victory and still have no final judgment. Meanwhile the stock has fallen 50% since these "court victories". Yeah, AMRN showed the FDA alright!
Highly unlikely that that is what they are discussing.
haha. AMRN owns the FDA? Now THAT is some funny stuff.
They may have gotten two court victories but there has been ZERO follow through and so far the court victories have amounted to nothing. No NCE, no final judgment. Scipts not impacted one bit by 1A. Stock down 50%. Yeah, everything is wonderful! AMRN owns the FDA!
And we all know that AMRN won't do that. AMRN is the FDA's whipping boy. And AMRN does not want to rock the boat.
Seriously?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=120650585
Obviously YOU thought it was possible otherwise why would you even bring it up?
You brought up as a possibility that the FDA would approve REDUCE-IT if the DMC recommended stoppage but AMRN decided to let the trial continue.
And meanwhile, people like Raf think they might approve REDUCE-IT without even seeing data.
Yeah, they appealed for buyout negotiations. Good grief crazy is everywhere on this board.
Raf, seriously man. Just take a break from the board for a while. At this point, after all these months of discussion, it just comes down to waiting to see what happens.
No. Not possible.
Apparently they do own 7m shares of the common stock. This doesn't show up on their quarterly 13F filings. And their 13G does not show up on the SEC filings for AMRN. But, it was filed, and here it is:
http://www.sec.gov/Archives/edgar/data/1080171/000101143816000417/form_sc13ga-amarin.htm
I have no idea why this ownership does not even show up on their year end 13F. I might be sending them an email asking for an explanation on this discrepancy.
That would be an amazing amazing result. However, the problem with that is that the chance of that happening is less than 0%.
Management is located in New Jersey. Not Ireland.
Got a link for that assertion?
ha...you can't be serious? You honestly are only including Aristeia in 12/31 and not 9/30, and claiming that it went up by 5m? That is hilarious and exemplifies that you are manipulating things to how YOU want them to be.
At 12/31/2014 Aristeia owned 9m shares
At 12/31/2015 Aristeia owned 7m shares
Now the issue was that this ownership is not being shown on their quarterly filings, which again, I don't understand why. But since we have annual filings two years in a row, it appears more safe to include it.
So under your theory, you are saying that for a 5m share increase to happen, Aristeia would have had to sell 9m shares during the first 9 months of the year, and then buy back 7m shares all during the 4th quarter? You know better than to assume that.
We can both agree the more realistic scenario is that they sold 2m shares at some point, or throughout, the year. So even assuming they sold 0 shares during the 4th quarter, ownership decreased by 1.3m shares.
We had no information concerning their 9/30 ownership, but the 12/31/2015 filing does confirm that they owned shares at 9/30. Somewhere between 7m and 9m. Going forward we won't have information on what they are doing until next year's 12/31/2016 filing.
How do you figure a 5m share increase?!
Per Whale Wisdom (which is "my method"):
Shares on 9/30/2015: 49,153,035
Shares on 12/31/2015: 47,819,258
That is a decrease of about 1.3m shares. Now the above number do not include Aristeia or Sofinnova, but if you add them to both 9/30 and 12/31, the movement doesn't change, just the total number of shares. It would still be a 1.3m share decrease. This even assumes Aristeia did not sell any shares during the quarter, although we do know they decreased their position by 2m shares at some point during the year.
So how are you getting a 5m share increase?!
Again, why would they make the deadline March 18th and not March 22, which would give them two extra days to digest no-NCE or NCE?
AMRN should get NCE regardless of whether they drop the 1A case, correct? So again, you want AMRN to drop this case to get something they should get anyway?! WHAT IS AMRN GETTING?
So far the best answer to what AMRN gets is an FDA promise that they will do something in the future. This should have been back in court months ago.
Unfathomable to think that AMRN would drop the case because the FDA promises they will review REDUCE-IT quickly. You obviously have learned NOTHING from the last several years. If AMRN agrees to that, they are dumber than I thought. The FDA could come up with a million reasons why they would need more time to review REDUCE-IT. Unthinkable that an FDA promise is enough for them to drop this case.
As for the post you reference, I have brought up previously that the Aristeia situation is confusing. I brought up the issues with HD. But based on their recent report, they own less shares now than they did on 12/31/2014, by about 2 million. The confusing points again, are that this ownership is not appearing on their 13F, and also the filing does not show up on AMRN's SEC filings page. As far as "no credibility", I did correct HD's way wrong numbers (he was double counting millions of shares). Also he continued to include Stonepine when I kept reminding him we have no idea if they own shares; turns out I was right as they reported 0 ownership at 12/31/2015.
Also you never replied to all response when you basically claimed PDUFAs are hard fast dates the FDA must abide by.
So AMRN gets an FDA PROMISE that they will do something in the future? And you don't think the second AMRN drops the case that promise goes away? WOW, you want them to drop this case because the FDA promises they will review REDUCE-IT quickly. WOW. Just wow.
But in your scenario, AMRN is getting nothing. If REDUCE-IT stopped early, your theory is that AMRN promotes REDUCE-IT and the FDA then approves REDUCE-IT in the meantime. This is nothing extra. AMRN has the PI, and they could have went for the final judgment by now, so they could already promote REDUCE-IT via the PI or final judgement. So nothing extra there. And if REDUCE-IT is stopped early, results would have to be great, so the FDA would presumably approve REDUCE-IT regardless of whether they settle or not. So nothing extra there. So what exactly is AMRN getting extra that they wouldn't have gotten if they didn't drop the 1A case?
You live in an extremely idealistic world. Do you have any experience working in an office setting that involves cooperation or correspondence between two or more companies?
It is a joint letter. Must be signed by both parties. And good luck getting FDA and AMRN employees together on something after 3pm on a Friday. Especially if this is all AMRN "strong arming" the FDA. You think the FDA is just gonna sign it A-ok, everything is good? You don't think there are layers of people at the FDA that would have to sign off on the FDA signing that joint letter? "takes 15 seconds", absurd statement.
So your theory is that 7 months into this, negotiations haven't even STARTED yet? And that if NCE is granted March 18th, then the discussions and negotiation begins? Theory doesn't make sense given the previous delays and amount of time this has been going on. If this was about NCE on March 18th, I would think they would have set a deadline a few days after March 18th, as NCE is usually granted around 3pm on that Friday. A lot to accomplish after 3pm on a Friday. Would have made more sense to give a new deadline of March 21 or March 22 under your scenario.
The whole idea that we have to wait until March 18th for things to even GET GOING is a pretty ridiculous idea. Not to mention that NCE is irrelevant to 1A promotion. Nice try, but you also previously thought it was "Cherry related" so you just keep changing your ideas every time a new delay comes in.
They own 15%+ stakes in many companies. AMRN is not a "substantial stake" for BB. They have an $11b portfolio. 15% in AMRN is peanuts for them. And most of that stake is convertible debt, which is a hell of a lot less skin in the game than owning shares.
Good to see. I figured he was going to get tired of being jerked around sooner or later. Continuing to manipulate a federal judge shouldn't stand any longer, and this Judge is seeing through the BS.
So the FDA gets what it wants 100% (case dropped) and AMRN gets nothing?
But again, what does AMRN get extra out of interim REDUCE-IT? I am still scratching my head as to what AMRN gets, that it wouldn't have gotten if they don't drop the 1A case. If it isn't stopped then it was all pointless (most likely outcome). And if it does happen to be stopped (extreme long shot), then how is AMRN better off dropping the 1A case? The 1A does not affect the quality of the data or timing of it's release. Please, someone explain it. And a faster review period is not an adequate answer.
If it was about interim, then what was the point of the first two deadlines? They were in October and December. If this whole thing is about Interim, then why would they have made those deadlines? Just a ruse? Knowingly lie to a federal court judge? Why not just make February 29 or March 31 the original deadline from the get-go (if the point was to get to interim)?
The FDA does not always abide by PDUFA dates. I have seen numerous occasions where the FDA failed to meet the PDUFA date. You are clearly not educated if you think the PDUFA is a hard fast date that the FDA must abide by. You need to get educated on how the FDA works. Below are examples of PDUFAs being delayed, and these were just found on PAGE ONE of a Google search. I could go on and on:
http://www.biospace.com/News/fda-delays-trimel-biopharmas-compleotrt0153-pdufa/321289
http://www.fdanews.com/articles/175339-fda-delays-sareptas-pdufa-date-of-dmd-candidate
http://www.nasdaq.com/article/biotech-stock-roundup-mannkind-pdufa-date-pushed-out-alkermes-impresses-with-data-analyst-blog-cm344863
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjmypSTw_3KAhUBVSYKHZQWAGoQFggcMAA&url=http%3A%2F%2Fwww.placementtracker.com%2Fnews%2Fnaturereviews.pdf&usg=AFQjCNEb_GOYg-0KRYCRl2OB_oAcugvzKA&sig2=3mnbmaN_X2rKTcvRBhmwvg&bvm=bv.114195076,d.dmo&cad=rja
http://www.businesswire.com/news/home/20150904005097/en/Alexion-Receives-Notification-PDUFA-Date-Extension-Kanuma%E2%84%A2
http://www.streetinsider.com/Analyst+Comments/PDUFA+Delay+on+Sustol+Seen+as+Minor+Setbck+for+Heron+Therapeutics+%28HRTX%29+-+Leerink/11222382.html
Because AMRN told us the goal was a final ruling. Did you listen to the last CC? That is apparently their goal and they let the FDA still run things. I am not the only person upset about this, others have also expressed their vehement frustration as well. It could be about language. It could be AMRN getting played by the FDA who keeps dangling carrots that will NEVER materialize. But, it is just another instance of AMRN being totally incapable of actually accomplishing something. This should have been a quite simple process: are you willing to give us a label expansion? The second the FDA says no or wavers in ambiguity, it should have been back to court. Done. Very simple. And yet this goes on and on. Someone wants to stall things, and the FDA is the one that benefits from no final ruling, correct?
Your whole "it is REDCUE-IT data related" makes zero sense. What does AMRN get extra that they wouldn't have already gotten? REDUCE-IT data is coming in regardless of whether or not they settle. The settlement has nothing to do with what the data says. So what exactly are they getting? Oh you are the proponent that the FDA will actually review the application faster, right? Ha....and I am the naive one? I, and AMRN, shouldn't be trusting the FDA to abide by their word or promises, that could be broken so fast you didn't even know what happened. They will never review the Vascepa application quickly, and you are dumb if you think they will. Plus the most likely outcome is no stoop at interim, so what do you think happens then?
Or do you think AMRN still fears the FDA, which explains why they are playing so nice with them? Sure is a possibility.
Either way AMRN is getting run over by the FDA in this instance. I can PROMISE you that AMRN is the one being manipulated by the FDA. It is so obvious I am sorry you cannot see it. As I laid out, this should have been quite simple to AMRN, and AMRN should have already taken this back to court months ago.
Why any date? This is the 4th deadline date set. What was the significance of any of the prior dates? Answer: none. Now all the sudden the deadline date is suppose to "mean something"? ha...please.
So we can expect the next delay to only be two weeks?
Absolutely pathetic. But hey, par for the course for AMRN. March 18th will be over 7 months since the original decision.
Disappointment and uncertainty = the name of the game with AMRN.
I guess if you are fine throwing $500 or more away it's A-Ok!
ha...he paid $1.34? Talk about overpaying. He obviously must not have been following this stock the last few weeks. HOD is always hit in the 1st hour of trading.