Replies to post #74672 on Amarin Corp Plc (AMRN)

[Whalatane]

Mog I would be very surprised if R-IT had a high drop out rate.

Vascepa is one of the easiest drugs ever developed to take .
None of the fishy breath of Lovaza
No muscle pains like the Statins.
No flushing from drugs like Niacin .

etc etc
Kiwi

[HDGabor]

M-

John F. Thero / Q3 2014 CC

In all likelihood, events in the study, because it is an events-driven study, will probably come from the 7,000-plus patients who are already enrolled.

Acc. to the protocol:

Before completing the enrollment phase of the trial, i.e. approximately 3- to 6-months prior to the projected enrollment of the 7990th patient, the actual event rate based on pooled, blinded accumulation of primary efficacy endpoint events will be calculated and plotted. If those analyses suggest the number of patients with at least 1 adjudicated, primary event (and appropriately accounting for patients with potential primary events for which the adjudication process is then incomplete) is consistent with projections, then the study could continue toward the protocol-specified target enrollment of 7990 patients.

If dropouts are higher (or event rate is lower) than they have been expecting then they would increase the enrollment. But they did not.

The delay is not important and could be due to several reason e.g.:
- AZN using a lot of (same) location also and they could pay more for the enrollment than Amarin
- they are looking for the "extremely" high risk patients

Summ:
- they won't enroll extra patients
- they don't have to enroll extra patients

Best,
G

[yellow_bluff]

a very likely reason that full enrollment here at the end has been so slow is that amrn does not want "bad luck" ahead of interim. say you complete enrollment in the next 2 weeks (they could if they wanted to), but unluckily, 10 guys that just enrolled and were getting vascepa, had heart attacks the next day after entering the trial. that would skew results against the company without enough time for things to normalize. after interim, and if there is no stop, expect the trial to finish enrollment literally in a flash.