Amarin Corp Plc (AMRN)

[HDGabor]

G-

the FDA was unable to inspect owing to Covid-19 travel restrictions, which ultimately led to the CRL.

Novartis is not the only one who is on the wrong end of the muzzle ...

It is a a new risk for all approvals (top of the "usual").
- It is not for ex-US facilities only
- FDA has a backlog of 1,000 site inspection (SI) ... just from 2020
- They had a 6-month period in 2020, when they did 3 (again three) ex-US SI and the US was minimal also.
- I am not privy to the details, but a cooperation agreement exists between the FDA and the EMA ... the EC approved Leqvio in Dec 2020. I assume the EMA inspected the facility.
- Contrary the "lucky" ones (below), the application should be filed again .. and in best case scenario it will get a Class 1 (2 months) review, but Class 2 (6 months) or standard (10 months) are more likely.

The "lucky" ones have a delayed PDUFA ... without new date. They do not have to resubmit, could be approved by "any" day.

Do not be surprised if some drug shortage will exist soon, since the FDA does not do the necessary reinspection (every/within 5 year), so the y stop a lot of transport (from not (re)inspected) facility) at the border.

Best,
G