Replies to post #31238 on Amarin Corp Plc (AMRN)

[BioChica]

The parameters for stopping the trial would have been set before the trial began. The parameters for trial design/early stopping would have been given to the DMC of course. The FDA does not provide specifics for the sponsor, regarding stopping a double blind trial. They simply should make sure analysis of data is done correctly for efficacy and safety. So the question would be, what numbers did Amarin decide on for early completion of trial!

It's all about how the data is analyzed when the data is unblinded!

Another FDA document insist's the FDA be contacted before a trial is stopped early.

Read section: E. Interim Analysis and Early Stopping (4.5)

FDA Guidance

[HDGabor]

I found the answer (?) for my own question:

"Special circumstances may dictate the need for an interim analysis that was not defined at the start of a trial"

and I guess high eff.% could be called special circumstances, so interim analysis could be done and if meet with stopping guideline the DMC will propose to stop the study.

[Whalatane]

HDgator

Excellent research ...thank you

My main takeaway is that we are locked into Interim analysis ( 967 ? events , 60% of events , expected early 2016 )

Its a question of can we get there before running out of $ ??

Biwatch raised an question in his GS link ...

John Thero " One could look at other opportunities for interim looks "...." " potential ways getting to results faster "
Based on FDA's attitude to Amarin to date , I'm not that hopeful .
JMO ,
I always appreciate your posts

Kiwi