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Thank you. Personally I think RI will be stopped next summer after the second interim look that will include about 90% of events. But hey you never know. Early stop this fall will be even better.
Gabor,
How about inclusion of additional secondary end points? Don't you think it makes stop at first interim less likely?
Wrong. The approaching interim is the primarily reason the sp is trending higher.
HD, Do you still believe RI will be stopped at Interim? It sounds like mgmt raised the bar really high by directing DMC to do not recommend a stop unless all primary & secondary end points are directionally favorable.
Where do you see that?
He's getting free shares. 25% vested in 1 year, 75% vested in 3 years. He pays $0. Nothing new here. AMRN mgmt is accustomed to a free ride on shareholders expense.
Ok. I misread his post. Probably because it simply didn't make sense to me.
If all 967 events required for the Interim analysis are already adjudicated why bring all patients again for the follow up visits? Just run the analysis.
But what management did I think is smart. By starting the follow-up visits before 967 events formally adjudicated they extended the process that will allow to capture more events for the Interim analysis.
It wasn't in "parallel". They started the process because according to their calculations the 967th even had already occurred.
No, he's not. That triangles "expert" makes more predictions than AMRN scripts out there. Complete joke.
This has nothing to do with communism. There should be checks and balances. Management should be compensated based on performance. They should not be allowed to award comp. packages themselves. This is ridiculous and completely wrong.
He's right. This is a crooked system. The CEO should not be receiving millions in compensation while investors are hammered and the company is a far cry from being profitable.
FDA will never approve anything without examining the data first.
Let's do not expect early stop at interim;)
I'm not suggesting Amarin should stop the trial on its own. But it's concerning to hear from Amarin mgmt that they advised DMC to do not recommend to stop the trial if it didn't hit all the secondary end points regardless of RRR in primary.
FDA f..ked Amarin so bad with Anchor that mgmt would rather unnecessary spend millions of shareholders money and waste almost another 2 years than demand justice and what we rightfully deserve.
That's nice but why all these great and complete data should come at our (shareholders) expense? If RI is not stopped at interim AMRN will have to spend $60mil more, wait another 18 months for results, and this is not to mention lost opportunity. FDA killed anchor that was going to help fund RI. Now they want more data for their "analysis"? We all know what FDA's analysis worth. We all witnessed ADCOM. If RRR at interim is 22% or better Amarin should stop the trial and seek immediate approval of Anchor & RI indications.
With all due respect $0.69 sounds just as rediculous as $8-10 you promised just a week ago.
What a flip flopper.
When was the last time you checked who sits on BOD? They feed each other on shareholders expense.
I don't know about that. But if true, should play well for us.
"Omthera is not marketed yet due to supply issues". Really? I think they have a lot bigger issue with their patents.
From what I've seen in the past few years, the only thing FDA whispers in AMRN ears is "go f..k yourself".
For the sake of all AMRN shareholders I hope you are right.
Management has zero trust in FDA's fair judgment after what FDA did to the company with Anchor indication. Therefore, it appears they would rather spend another $60mil or so and 1.5 years on running RI to the end than risking stopping RI at the interim. They already spend a lot of time & $$$ on RI. They can't afford to allow FDA to derail it only because one or two secondary end points were not significant enough at the interim analysis.
At least that's how management sounds to me.
Exactly. Red flags? Please. Remember those crazy options traded for a huge profit one date before ADCOM docs were released. It was such an obvious inside trade. Did anyone go to jail for that? No. It wasn't even investigated.
Sorry, I didn't mean to offend you. We just had way too many "bulls" with crazy estimates. Almost all of them turned out to be wrong for various reasons.
You remind me of those who were predicting a BO $20 with NCE $30 w/o. Most likely you were one of them.
We don't need that scumbag any near AMRN.
G,
If the 967th event occurred let's say on March 15th to what RRR range it would translate based on your estimates?
No, they won't because it will mean more work for them than they are being paid for. DMC will simply recommend to continue the study.
Correct. And canceling margin account means you will have to wait 3 days for funds to clear before you can trade again. Very inconvenient.
It's very simple actually. He wants it to be under 5.2 so DMC recommends to continue the study. AMRN dilutes to get enough $$$ to finish RI. PPS drops and KIWI buys cheap shares.
This guy is pathetic. I wouldn't pay too much attention to him.
I've been hearing this song for years now. PFE, MRK, GSK, TEVA, AZN, ELN. Management and their attitude towards company shareholders is our biggest problem. They treat this company as their personal ATM.
It would be nice to finally get over with NCE drama. Four years and $12 later;)
What is your take on NCE? Do you think FDA will finally award us NCE this Friday?
Sure it can. It takes time to record and report these type of events. RI is a global study with many countries involved. Also remember DMC meets once a quarter to review RI data.
How about it was reached, but not reported by DMC yet. Did you consider that scenario?
I'm sure management would issue a PR if DMC informed them that the interim was reached along with their recommendation. The bigger question is how much time is between 967th event and DMC recommendation.
DMC meets once a quarter to review the data. Does it mean that the gap might be up to three months?
I think you nailed it. What is your take on efficacy?
Unfortunately the pps will be driven by speculators for the most part which will make it unpredictable.
Look at KBIO one day it was $0.75 next day it jumps to $40 pps and few days later the company is a bankrupt again. WS is a crazy place where predictions don't work.
Kiwi,
There are two variables in this equation. First, interim in H1 2016.
Second, RI ends in 2017.
Now in order for RI hit all events before the end of 2017, interim should occure about now. Otherwise the study will spill into 2018 and this is not what management suggested.
Good point. But if we choose to stick to management's guidelines the interim will happen a lot sooner than June 30th.
Good point. But if we choose to stick to management's guidelines the interim will happen a lot sooner than June 30th.