Replies to post #410607 on Amarin Corp Plc (AMRN)

[ziploc_1]

Nsleven...re Brave study
"Primary Completion: "April 2021 [Anticipated] September 29, 2023 [Anticipated]
Study Completion: April 2021 [Anticipated] September 29, 2023 [Anticipated]"

The 'primary completion' date and the "study completion date' are now both both 'anticipated" to be September 29, 2023

My understanding of this change of dates means that this study was extended for over 2 years...Imho these scientists, who have dedicated themselves to finding solutions for Alzheimers, would not have extended the Brave study unless they were seeing some good results, but still waiting for statistical significance(which is unlikely to be achieved due to the small sample)...but, even without statistical significance, the FDA could approve a drug like Vascepa for AD, since it has a proven safety record... if it is case that the results are trending positive in a disease which has no really good alternative treatments.

[Whalatane]

What is the purpose of a Data Monitoring Committee.? Seriously ?

First and foremost it's to check for adverse events and how serious these are.
Trials get stopped largely because of serious adverse events showing up.

If there's a serious difference between rates of severe diarrhea between the placebo arm and the active arm ...do we really want to continue the trial even if the drug in the active arm may be showing some efficacy in treating the disease. ...?

There's no harm ( other than what's already been identified --- slightly more AFib and slight increase in bleeding risk ) using Vascepa ...and if the placebo is truly inert ( forgot what they were using in this trial ) ...keep running the trial .
It may take until the last yr of the trial to see benefit ( if any ) anyway

Kiwi