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I doubt. I'm sure they will cover shortly. Those ppl aren't idiots. They are in for a quick buck.
He or whoever is behind him already shorted. Read the disclosure. That's their game plan. Short the stock and put out a hit piece to scare hell out of retail longs and short even more to drive the PPS down.
Hedges do it all the time ahead of major binary events when it's the easiest to spook ppl.
We even got one on this board who got spooked today. But he gets spooked all the time so I'm not sure if that even counts. lol
I think we'll see 3.5 before 2.5 unless PR hits first.
I would agree if he was selling at highs and buying at lows. He doesn't.
FFS,
Did you get spooked and sold again? That's crazy!
tmac, and of course Anchor was very unsuccessful as it took 18 days from data unblinding to top line results release. RI data was unblinded in early September. Probably on September 4th right after the Labor day. That's about 10 days as of today.
There you go.
https://finance.yahoo.com/news/reduce-trial-primary-results-accepted-132101551.html
BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 12, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced that the primary results of Amarin’s cardiovascular outcomes study of Vascepa, the REDUCE-IT study, have been accepted for presentation at the 2018 Scientific Sessions of American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois. The presentation, classified as late-breaking clinical trial results, is scheduled to commence at 2:16 pm Central Time and listed as Main Event 1 for that timeframe. A link to this notice is provided at: http://www.abstractsonline.com/pp8/#!/4682/presentation/59402. This acceptance as a presentation of late-breaking clinical trial results is based on the ability of REDUCE-IT to address a critical question in cardiovascular prevention. The AHA has reviewed the design of the REDUCE-IT study, however, they have not yet seen the results of the study. As Amarin has guided in the past, topline results of this study are anticipated to be made public prior to the end of this month, September 2018.
JT does care about the share price. I think the last CC couple weeks ago after failed ASCEND study made it clear.
After today's PR and shorts attack. I think JT will get results out as soon as they are ready. If I were him I wouldn't be waiting for Monday.
I would be shocked if RI doesn't deliver 10% RRR. But >15% would make it worry free ride all the way to FDA label approval. We don't need another ADCOM drama.
Ziploc,
Agreed. As a matter of fact I just added more in both my 401k and cash accounts as I think this is the very last opportunity to add.
PR within days if not hours.
No doubt Amarin has the results and them deciding to proceed with the conference in November makes me believe the results are positive.
"The AHA has reviewed the design of the REDUCE-IT study, however, they have not yet seen the results of the study. As Amarin has guided in the past, topline results of this study are anticipated to be made public prior to the end of this month, September 2018." - in other words Amarin knows the results and will make them public soon but meanwhile Amarin is securing a spot at AHA to present the results.
If results didn't look good, I doubt Amarin would care about presenting them.
I guess this is the bear raid many here anticipated right before the results. Next step is a long awaited PR.
VTL reported failed p3 and the stock is down 90%. Brutal.
That's a stretch but I hope you are right.
The last deadline for submission was in mid August.
https://professional.heart.org/professional/EducationMeetings/MeetingsLiveCME/ScientificSessions/UCM_323242_Submit-Science.jsp
I think it's obvious Reduce-it being presented at AHA in November cannot be viewed right now as a confirmation of positive results. The company registered for this 10min session months ago, way before the DB lock. No way the company knew at that point whether results are positive or not. They just reserved a spot as they knew the results will be available by November. Smart move but not a confirmation.
FDA will act based on what? Amarin's word that the results look good? lol
FDA will wait for the data submission. It will review it. Most likely schedule ADCOM and make a decision sometime in 2019.
BB,
I might be wrong but I doubt FDA will be able to act until they received a full set of RI data from Amarin to review and this will take some time.
Sorry here is the link.
https://pca.st/NL8I
Isaeed,
I shared this link yesterday. Very interesting and informative podcase on EPA/DHA. The doc mentioned that for the bleeding to become a real concern you need to consume at least 20g of Omega3 a day. That makes me believe 4g EPA/day isn't an issue.
I perfectly remember a moment when FDA guy (after being criticized by committee members) asked if the voting question should be changed. After a moment of silence the other FDA guy jumped in and shut that idea.
IMO that moment of silence was an opportunity for Amarin to jump in and try to divert Titanic. But Amarin team remained silent.
BB,
PR release on Mondays is a pattern but not the rule. I think JT will drop a PR whenever it's ready.
BioChica,
It's no longer about DMC. The data is being analysed by the team of Amarin representatives and outside experts. I'm sure Amarin reps filled in JT on the status.
I'm sure JT already knows top line results.
Kenji,
Very true. The only thing I would disagree is that Amarin could not anticipate the ambush. Remember Amarin team met with FDA just before V approval. Amarin chose to do not inform shareholders about substance of that meeting. AF speculated FDA informed Amarin that they do not plan to grant NCE status. Meanwhile Amarin kept its investors in the dark for many months after the approval until FDA verdict finally came through. Another bad sign was that JZ was not present at Anchor ADCOM. That was telling. So I can't say there weren't any warning signs.
I'm sure JZ's stupid remarks intended to fuel speculations and inflate the sp did not make a good impression on FDA.
Ziploc,
They could have done it nicely in a very polite and professional way. I just felt like they didn't have the right guy on their team to step in and make an argument when they had a chance to turn things around.
In other instances some Amarin guys looked way too nervous and unprepared.
Sorry about spelling. Autocorrect on my phone is terrible.
He's absolutely right. I watched ADCOM life. Amarin team wasn't well prepared and didn't put up a fight. At some point, when the voting members criticized FDA for not playing fair with small Amarin, FDA almost backed off. FDA guy asked if a voting question should be changed? This is the moment when Amarin had it chance. But nobody from Amarin team stepped up. Nobody made a push over the tipping point and FDA went ahead with it's original voting question that didn't leave any choice to the voting members but to vote "No".
Was it an ambush by FDA? No doubt! Was it fair to Amarin and it's shares, patients? He'll no! But at the same time IMO Amarin did had its tiny chance to turn things around and they simply didn't have the right leader on their team. Someone bright and passionate to turn things around when opportunity arose.
About a year later I watched another ADCOM. The name of the company was Chelsea Pharmacuticals. It was a very simulator situation with a strong pushback from FDA. They also had their tipping point at ADCOM and Chelsea guy put up a fight and won. FDA backed off. The docs voted favorably. Shortly FDA approved the drug and the company was bought out just a few weeks later.
Interesting company reviews by current and ex. employees.
Overall ranking is 2.8 which is low.
One employee made a comment that if RI is successful the company will be sold immediately.
https://www.glassdoor.com/Reviews/Amarin-Reviews-E7326_P3.htm
Interesting podcast on O3 as a remedy for traumatic brain injury. The guy recommends 3g/day as a preventative measure and whopping 15g/day as a remedy in case of injury.
O3 brings ppl back from coma...
https://pca.st/NL8I
September 24th? That's a far cry from your August 13th prediction.
JL,
I suggest you go back and re-read my posts. You tend to make wrong assumptions that lead to wrong conclusions. And no, of course I'm not in Hungary. But I know an awesome dude who is:)
JL,
Is it not exactly what I did? My original expectation for the top line results was 9/10. But after HDG's post with Anchor timeline I adjusted my expectation to 9/17-9/24.
I don't think it can go much longer than that unless Amarin has no clue on the timelines they provide.
In your reply to me you stated that results analysis for Anchor and RI is oranges vs. watermelons. Anchor is much simpler. I stated that while I agree with in general, the timeline for the top line results should be somewhat similar. Otherwise we'll be way past end of September.
JL,
I think you completely misunderstood my point. But that's ok. That's probably because, as you already admitted, you are not an expert in trial design and data analysis.
And before you suggest others to limit their posts why don't you stop posting about your Harvard diploma and other great accomplishments that have nothing to do with Amarin.
JT IMO.
Raf,
You've done nothing. HDG did.