Replies to post #186391 on Amarin Corp Plc (AMRN)

[ggwpq]

I have posted this before but worth to repeat again. Note that INSM's NDA filing date was 3/29/18 while AMRN's sNDA filing was 3/28/19, exactly 1 year time shift. That means we can use INSM timeline to track AMRN's sNDA progress. I am 99% confident AMRN will get priority approval on or before 9/27/2019 (Friday)


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A recent example of priority review with adcom panel : Insmed

3/29/18 : Insmed summits new drug application to the FDA

http://investor.insmed.com/2018-03-29-Insmed-Submits-New-Drug-Application-to-FDA-for-ALIS-in-NTM-Lung-Disease-Caused-by-MAC

5/16/18 : FDA acceptance of NDA with priority review announcement

http://investor.insmed.com/2018-05-16-nsmed-Announces-FDA-Acceptance-for-Filing-of-New-Drug-Application-for-ALIS-in-NTM-Lung-Disease-Caused-by-MAC

6/15/18 : FDA Adcom meeting announcement

http://investor.insmed.com/2018-06-15-Insmed-Announces-FDA-Advisory-Committee-Meeting-to-Review-ALIS-as-a-treatment-for-NTM-Lung-Disease-Caused-by-MAC


8/7/18 : FDA Advisory Committee Votes 12-2 in Favor

http://investor.insmed.com/2018-08-27-FDA-Advisory-Committee-Votes-12-2-in-Favor-of-the-Safety-and-Effectiveness-of-Insmeds-ALIS-for-the-Treatment-of-NTM-Lung-Disease-Caused-by-MAC-for-Adult-Patients-with-Limited-or-No-Treatment-Options


9/28/18 : Insmed Announces FDA Approval of ARIKAYCE

http://investor.insmed.com/2018-09-28-Insmed-Announces-FDA-Approval-of-ARIKAYCE-R-amikacin-liposome-inhalation-suspension-the-First-and-Only-Therapy-Specifically-Indicated-for-the-Treatment-of-Mycobacterium-Avium-Complex-MAC-Lung-Disease-in-Adult-Patients-with-Limited-or-No-Alterna

Hopefully Amarin would follow the same path as Insmed.