Amarin Corp Plc (AMRN)

[HDGabor]

I do not have nay proof that confirm that they get data in every quarter, however the DMC has a meeting on a quarterly basis.

JT said:

"And our enrollment to date, it's a trial designed around -- for 8,000 patients. We have over 6,800 enrolled, representing about 85% of the total. The mean and median baseline triglyceride levels for, you know, patients being enrolled in the study are north of 200 milligrams per deciliter, which is what we had wanted it to be. We think that that's the right pegging from a risk profile.

We are of course blinded to the results of the study. There is an independent data safety monitoring committee that regularly looks at the study from a safety perspective and regularly has, you know, gives us the thumbs-up for continuing the study."

Guidance for Clinical Trial Sponsors

4.3.1.2. Meeting Structure

" many DMC meetings include an "open" session in which information in the open report is discussed. These non-confidential data may include, for example, status of recruitment, baseline characteristics, ineligibility rate, accuracy and timeliness of data submissions, and other administrative data. Sponsors may also use open sessions to provide external data to the DMC that may be relevant to the study being monitored. Open session discussions might include representatives of the sponsor, steering committee, study investigators, FDA representatives, or others with trial responsibilities. There is a benefit to having a wider attendance at these sessions, since they provide an opportunity for those with the most intimate knowledge of the study to share their insights with the DMC and raise issues for the DMC to consider..."

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"FDA will reinstate the SPA supported by MPC recommendation on (or before) 08/14." - 08/14 as a date of MPC recommendation