Amarin Corp Plc (AMRN)

[Biobillionair]

Regarding mid-cycle review:

Amarin has not been notified of mid-cycle review, this does not mean mid-cycle review did not occur on Friday.

According to my DD, the mid-cycle review does not include sponsor participation. Instead the review team meets with the signing authorities responsible for the final approval of the sNDA. As you might guess this will likely be Woodcock signing off on this approval.

Janet’s prettying tuned into my perception of the review thus far so hopefully she got full clarity at the mid-cycle review meeting to make sure everything is on schedule for approval before or on PDUFA date. I mention “before” because no Ad Com is a factor in earlier than PDUFA date according to my DD of the 21st Century review desk reference.

Some of the communication issues between Amarin and FDA arise the perception of whether or not Vascepa reviews are part of the “program”. What’s the “program”? Read this:
https://www.fda.gov/industry/prescription-drug-user-fee-amendments/program-enhanced-review-transparency-and-communication-nme-ndas-and-original-blas

In my opinion based on the FDA current status of Vascepa’s chemical classification; the FDA DOES NOT consider Vascepa a program drug. What!!!? How can this be...? Well if you haven’t already noticed the FDA can be quite arbitrary and capricious when it comes to Amarin and Vascepa; despite the order from Judge Moss the FDA still classifies Vascepa as a type 5 New Formulation, in other words just another me too drug wasting the FDA’s precious time. Here’s the classification: Type 5 - New Formulation or New Manufacturer

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process

Contrasting the crappy me too Drug Vascepa to the NCE classification of Lovaza:
Type 1 - New Molecular Entity
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process

From the above FDA documents you can see the FDA could care less about the Moss ruling. The FDA has not and IMO currently not including Vascepa as a “program” drug.

Not being a program drug places Amarin in a lower tiered communication expectation according to my DD on 21st Century reviews.

I’ve attempted to get Amarin’s head out of their asses early on in the review process regarding type-5 classification but was pretty much blown off by JT...”he’ll forward it to the review team”...whatever!

Amarin needs to take this back to Moss court ASAP. The FDA needs to be ordered to change the classification of Type-5 to Type-1 before my head explodes in a green furry of e-mails to several Senate members, attorneys and CEO’s.

BB