Amarin Corp Plc (AMRN)

[Jamaalish]

Found an article that might give some insight into the FDA's attitude towards V's label. The article may not apply to V and instead be limited to the FDA's stance towards more difficult to treat diseases and orphan drugs. Not certain. But in the very least, it shows a willingness by the FDA to make exceptions in some cases. Here is the most interesting paragraph:

"The FDA’s more flexible stance towards drug development in recent years has resulted in some drugs for orphan diseases being approved for use beyond what was studied in clinical trials. During the SVB Leerink event, Woodcock said the agency is open to doing that if it’s clear the therapy’s mechanism of action could benefit a wider group of patients."

Here is the full article:

https://www.fiercepharma.com/pharma/fda-promises-elevated-new-drug-approvals-but-warns-potential-pitfalls-report