Replies to post #53472 on Amarin Corp Plc (AMRN)

[Williams4076]

Zum,
The patent details contains specifics on REDUCE-IT structure....I'm almost afraid to read further

REDUCE-IT study banks blood to be genetically studied at further date...cool!

JL please look at (0390) before I snap an opinion out.... Case Report Form (CRF)
Does Amarin track CRF as safety issues? FDA CRL requested REDUCEIT safety info, your prediction was when again;)

BB

[Williams4076]

Zum-

This is the full instruction sheet for REDUCE-IT. It contains the steps the FDA has approved, which include Amarin to be notified of "safety" issues. FDA requested "safety" issues in the Anchor CRL. These safety issues could be actual events or some other random issue with drug or placebo; all CRF are analyzed by the sponsor in the protocol.

https://dl.dropboxusercontent.com/u/57678878/R-It%20patent%20%20app%20PCTUS1348559.pdf

This is a GREAT find!!!

BB

[Sam81]

The most interesting part is the 3-6m prior to full enrollment; if analyses suggest the nb of patients is consistent with projections -->continue towards 7990 patients. If nb of events appears less than and inconsistent with projections, the sponsor will recalculate nb of needed patients to achieve nb of target events...i guess we are in the 3-6m period & no PR issued yet mentioning the need to increase patient nbs. Positive for red-it as all is consistent with projections
Your thoughts are highly appreciated it especially ZUM / JL / BB / HB...and all the rest :)