Amarin Corp Plc (AMRN)

[HDGabor]

v-

I honestly thought that the 74 day letter gave the FDA's "intention" whether or not that they were leaning towards an adcom.

We know that the “Priority Review Determination” letter (the day-74 letter … May 28/29, 2019) does not contain anything about AC …

FDA did not indicate whether it plans to hold an advisory committee (AdCom) meeting to discuss this application

If there are filing issues (not likely … just to cover this scenario also) but FDA was not ready to send the “Filing Issues Identified” letter to Amarin together with “Priority Review Determination” letter then the “Filing Issues Identified” letter was "due" by June 10. … It is fair to assume (as of today): FDA did not indicate in the “Filing Issues Identified” letter (if any) whether it plans to hold an advisory committee (AdCom) meeting to discuss this application.

Base case: no AdCom

I was definitely with BB expecting a PR today regarding no adcom based on the information I found

FDA won't say a "no AdCom" till the review will be complete *, since

if issues arise during the review, a decision to hold an AC meeting may be made later

* "due" by end of July ("FDA’s goal is to complete all GCP, GLP, and GMP inspections and Compliance review … within 6 months for priority applications. This will provide 2 months at the end of the cycle for the applicant to address identified deficiencies." … Please note: the 6 months is for NMEs … is 4 month in this case.)

Meanwhile "issues arise during the review" could not be ruled out the chance is slim to none.

Sum:
- no AdCom
- FDA won't say anything about AdCom … will approve the sNDA on or before September 27 (later than August 1)

Best,
G