Replies to post #70409 on Amarin Corp Plc (AMRN)

[rafunrafun]

"Which it is a highly unlikely event" - only according to you that JELIS subgroup-like result would result in continuance.

[HDGabor]

M-

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?

First of all your example means at least 15% RRR, since the patients enrolled during the last 1-1.5 year and on V does not have an event ...

The result will be a definitely a B&W regarding the hypothesis. The RRR will be x% and other results will be y, z, etc. The criteria and the stopping boundary was well defined. e.g. RRR has to be over 22%.
- if it is lower it will be continued,
- if it will be higher, but sthing other won't reach the pre-specified value, it will be continued
- if it will be higher and all other will reach the pre-specified value, it will be stopped

The result could suggest additional indication / benefit for a sub-group, but won't be confusing regarding the basic assumption.

The trial goes on. The FDA could use an early stoppage to again sabotage AMRN.

Maybe you missed it:

an overwhelming efficacy boundary that is pre-specified ... and the protocol that was the subject of the FDA agreement. So there was obviously also discussion with FDA to arrive at those provisions.

DMC recommendation will be based on facts and not on theory. Furthermore R-IT will have a clinical result, meanwhile ANCHOR had a laboratory. Never say never, but no way that FDA could challenge the facts and the numbers.

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.

Why? Why not the Japanese (sponsor of JELIS)?

Best,
G

[L0tsaluck2000]

As usual Mog, you,are off off on facts and interpretation. First, expectations are not high -if they were the stock price would be several times higher. The company has done nothing to create high expectations - if anything they have been unnecessarily conservative still trying to live down the "more offers than employees" saga.

Interestingly, the folks that do have some expectations tend to have some extremely impressive credentials with tremendous effort spent researching all of the science of EPA. These folks have far move knowledge of the probabilities than the run of the mill analyst or for that matter the run of the mill medical doctor. Believe me the folks on this board do not have a naive knowledge of the probabilities and risks. They have certainly learned there are no sure bets with Amrn - but they are making highly informed bets.

P.s. I hope you live alone - I would feel sorry for anyone who had to put up with your negative arrogant attitude on a full time basis.