Amarin Corp Plc (AMRN)

[MedResCollab]

HDGabor,

Yes, well aware the Filing Communication is the day-74 letter.

No 60-day letter exists … the 74-day letter is due by day 60 in case of Priority Review. The FDA send two letter - in case of Priority Review - if there are filing issues but they are not ready to send to applicant by day-60. In this case they send the “Priority Review Determination” letter by day60 then send the “Filing Issues Identified” Letter by day-74. … Isn't a likely scenario, more likely FDA sent the “No Filing Issues Identified” letter together with “Priority Review Determination” letter. -HDGabor

Some of what you write above is correct, but your statement that “the 74-day letter is due by day 60 in case of Priority Review” is not.

As you mention, for a Priority Review, the regulatory project manager (RPM) prepares one of the following three communication types:

1. If there are filing issues but they are not ready to send to applicant by day-60, send the “Priority Review Determination” letter by day-60 then send the “Filing Issues Identified” Letter by day-74.
2. If there are filing issues and they are ready to send to the applicant by day-60, send the “Filing Issues Identified” letter by day-60.
3. If there are no filing issues, send the “No Filing Issues Identified” letter to the applicant by day-60.

A day-74 letter, or Filing Communication, however, is always sent, and always sent by day-74 (goal in any event), hence how it acquired the moniker. It is sent regardless of whether or not any filing issues were identified beforehand. The day-74 letter is an essential communication that contains some or all of the following:

-any filing issues identified but not yet communicated to the sponsor by day 60, or the communication that none were found
-the planned timeline for review activities, such as target dates for transmitting initial labeling and PMR/PMC comments
-the planned date for mid-cycle review (normally ~3 months after acceptance of application for Priority Review apps)
-preliminary plans to hold an Advisory Committee (AC), if applicable, and date if determined yet. If not determined yet, will be relayed at mid-cycle meeting (see above)

We can see how one would confuse the goal to send the “(No) Filing Issues Identified” letter no later than day 74 with the “day-74 letter,” or “Filing Communication,” which does include it if it wasn’t already sent.

Regarding the CEO’s comments, apparently the day-74 letter had not yet been received by the GS conference. Sometimes it is a bit late. In any event, insiders are not required to report private communications with the FDA, including the contents of the Filing Communication, and in this instance will most commonly wait for a date to be set on a planned AC and communicated to them (often by mid cycle meeting) before reporting this to the public.

3 months from March 28 would be end of this month. Still time.

Regards,
-MRC Team