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sts66

12/03/13 5:00 PM

#22444 RE: DeepBreath #22442

But if Amarin does abandon the trial, is there an alternative? Some cholesterol experts I’ve spoken with believe the NHLBI should pick up the trial if it is abandoned. It’s unclear how this could happen, or if it’s even possible, but the fact is that the REDUCE-IT trial is testing a very important hypothesis, with significant implications for many other drugs besides Vascepa. There are no other trials on the horizon that are likely to shed so much light on this vital topic.

Apparently the FDA doesn't believe the above statements.....and how does AMRN benefit if the reins to the trial are taken over by the NHLBI? Of course they'd save the cash, but wouldn't they also lose control of the trial and any data it reveals? Meaning that they'd have to use "someone else's data" in order to file an sNDA, not exactly kosher?
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epenephrine

12/03/13 7:26 PM

#22447 RE: DeepBreath #22442

Deepbreath....what experts are talking about the NHLBI picking up the reduce-it study?