Replies to post #328013 on Amarin Corp Plc (AMRN)

[concapk]

abe1234

just can't help yourself !!!!

[rafunrafun]

That is a very important thing that you posted.

I have done literally 0 DD on Europe and have relied on others' DD. It was my understanding that 67 days is the maximum time frame for EU approval. The example you gave shows that this isn't so... unless I'm missing something.

It is important because if we reach day 68 and we haven't received the approval, panic will occur, especially from the ones who (like me) thought that 67 is the maximum.

[HDGabor]

An example is Lumoxiti. It was recommended by CHMP Dec 7,2020. It has not been approved by EMA as of yet.

Really?

(2021)928 of 08 Feb 2021

Next one ...?

[lettruthringout]

Lumoxiti is having orphan status re-reviewed.

That is the hold up.

[Freifaller]

7-10 December 2020 CHMP meeting

Enhertu - approved by EC 18.01.2021
Hepislav B - approved by EC 18.02.2021
Inrebic - approved by EC 08.02.2021
Lumoxiti - approved by EC 09.02.2021

Link for Lumoxiti approval:
https://ec.europa.eu/health/documents/community-register/html/h1522.htm

[HDGabor]

go through all of them and you can see there are few still pending approval from EMA.

Which one - other than Sibnayal* - is pending ...?

* This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained