Replies to post #104889 on Amarin Corp Plc (AMRN)

[rafunrafun]

No. Everyone but DMC are blinded. DMC will make either of the 2 recommendations, STOP or CONTINUE. If it's "CONTINUE", exact same will happen as it did at 60%. If it's "STOP", Amarin will follow their recommendation and will seek Reduce-It label.

[ziploc_1]

L:.....Anchor was about Vascepa lowering triglycerides. The data showing success in that study is already out and can be promoted by Amarin even though the FDA did not give Anchor a label.... R-IT is about Vascepa lowering CVE.... The data will be released only upon stoppage of the study and will probably also be promoted by Amarin even before an FDA label. A successful result of R-IT will be noted in the newspapers and medical journals and will stimulate Docs to prescribe Vascepa off label even before the FDA acts.

[Biobillionair]

The actual sNDA 005 I believe is administratively dead, unless Amarin and the FDA have a plan that hasn't been publicly disclosed. Is there an early view into the data? It's possible, I do believe the FDA has formalized final guidance on this back in 2015. Do you want me to post it?
BB

Here:
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf

https://www.fda.gov/regulatoryinformation/guidances/ucm127069.htm

Other articles:
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.128.5739&rep=rep1&type=pdf

Here's the public hearing on the matter:
https://www.fda.gov/downloads/drugs/newsevents/ucm436369.pdf

[VuBru]

Laura - No - Not possible.