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Re: Please STOP IT!Bottom line-how do you think that this will eventually play out? Is Amarin a buy at these levels for the long run or not? I dunno Gary. I have “hopes” on how it will play out, but I recognize it could go the other way. You note “the long run” above and indeed it may be the long run. The interim stopping rules may be very stringent (ala PARADIGM-HF) and this may need to go all the way to trial conclusion. I do think REDUCE-IT will ultimately be successful (though far from a certainty). It could be a long rough ride to get there. I do not subscribe to the conspiracy theories.
I do not (at this point in time) have any reason to blame management. You play the hand you’re dealt. When I first started following AMRN I was impressed that management under-promised and over-delivered. Both MARINE and ANCHOR enrollment was completed earlier than guided. Top line results came earlier than guided also. Unfortunately, it now seems REDUCE-IT enrollment is falling behind projections (even considering the slow down due to the change from 150 to 200 mg/dl trig requirement). I do not foresee the potential for a stop any earlier than the first interim. W/o changing the protocol to prospectively add an earlier interim it would be a disaster. I hope AMRN management knows this. Recall the Sunitinib trial in PNET that stopped early at an unplanned interim. Their DSMB reviewed unblinded efficacy data frequently and saw an early trend. They stopped at an unplanned interim analysis. It was a big eff-up. Sutent didn’t win approval in that indication for another 2.5 years. Was it ethical to stop early and make the drug available to patients in the trial? Was it ethical to stop prior to collecting sufficiently compelling evidence required for regulatory approval? As it turned out, the patients in the trial were crossed but those diagnosed over the following 2 years didn’t have access to the drug. Individual ethics vs group ethics. If Amarin wanted to entertain the notion for an earlier stop they could have amended the protocol and added an earlier interim (a suggestion I made to management some time ago via email). It is curious the recent PR commitment to continue REDUCE-IT “as planned”. I have a fantasy (read: essentially zero chance of occurring) that the FDA might take an unscheduled agency peek (exclusive to JUST the agency) at the efficacy data prior to ruling on the sNDA (as they did with Yervoy). The main threat of any “peek” is the introduction of bias in an ongoing trial by way of changes to the trial. If the sponsor commits to continue “as planned” that threat is somewhat mitigated. (many months ago I sent AMRN an email pointing them in the direction of the YERVOY precedent for an agency exclusive interim peek – no response but you never know. We could wake up one morning and find that the ANCHOR indication was approved).
Yeah, that’s a pipe dream and it is NOT why I’m still invested here. |
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Msg # | Subject | Author | Recs | Date Posted |
1649 | Re: Please STOP IT! | garynavarre | 0 | 10/15/2014 8:12:03 PM |