Replies to post #163979 on Amarin Corp Plc (AMRN)

[north40000]

Thanks. That may be the case I was thinking of from MEDX, BMY and MRK investments. Did AZN also have a fast one like BMY's Opdivo?

[io_io]

What is the shortest time you have seen for the FDA to conduct a review within the priority review time frame and approve an expanded label request?
one week after granting priority review...
https://www.fiercepharma.com/regulatory/fda-approves-bms-opdivo-for-kidney-cancer-a-week-after-granting-priority-review

The FDA does have a new policy whereby trial data can be submitted "real-time" and before the actual application filing; it is limited to sNDA's and sBLA's, but unfortunately it is also (at least for now?!) limited to just cancer drugs - LINK

However, at least this new policy shows that the FDA climate is good for accelerated priority review when the need is critical.