Replies to post #135588 on Amarin Corp Plc (AMRN)

[me33]

And the headlines will be RI study fails to achieve statistical significants in PE, but showed some promising trends in certain SEs.
I can guarantee you the market is not going to like it and will punish the stock and FDA will of course has its doubts.
Amarin will be in survival mode. We don't want that. We need stat. significant PE. Period.

[HDGabor]

JL-

Correction: "If key SE will fail (miss the required p value) none of the SEs could be stat. significant."

[0583] Secondary Endpoints
[0584] The statistical analyses of the secondary endpoints will be analyzed by the same log-rank test specified above for the primary efficacy endpoint. Treatment differences will be tested at alpha level of 0.05 using a sequential procedure for controlling type 1 error starting with the key secondary variable. The remaining secondary variables will be tested in the order specified in Section 9.2.2. Estimates of the hazard ratios from the Cox proportional hazard model and the associated 95% confidence intervals will also be provided. Kaplan-Meier estimates from
randomization the time to the secondary efficacy endpoints will be plotted.
[0585] Tertiary Endpoints
[0586] For event rates, the statistical analyses of the tertiary endpoints will be similar to the analysis of the secondary efficacy endpoints. All tertiary analyses will be conducted for the ITT population. No adjustments for multiple testing will be made.

Best,
G