Amarin Corp Plc (AMRN)

[Atom0aks]

Right. Again, which is why I said I ignore the words he puts inbetween and only check his evidence.

For example, on p. 32 of the Desk Reference Guide provided on the FDA website (https://www.fda.gov/media/78941/download) under the heading, "4 Conduct the Review" the reference states,

"An Advisory Committee meeting may be held for one or more of the following reasons. Note that this is not an exhaustive list.
1. The application is an NME.
2. The clinical trial design used novel clinical or surrogate endpoints.
3. There are significant issues regarding safety and/or effectiveness of the drug or biologic.
4. The application raises significant public health questions regarding the role of the drug or biologic in the treatment or prevention of a disease."

One of these reasons is why we are having an AdCom, not the other BS that's circulating around here.

On the very next page, p. 33, is the following,

"AC Meeting Preparation: The RPM schedules at least two practice sessions for internal participants (OSE staff should be invited to all planning meetings relevant to REMS, PMRs/PMCs, or other safety issues). Presenters are selected based on expertise, familiarity with the data, and presentation abilities. The division director should attend the practice sessions. The office director should attend the final practice session. Attendees include presenters, representatives from each consulting group, team leaders and the RPM.

About 6-8 weeks before AC meeting the following activities take place:
• DFO handles logistics for scheduling meeting, publishing Federal Register notice of the meeting, sending the meeting background package to the applicant, and obtaining security clearances for Special Government Employee (SGE) committee members and consultants, and guest speakers.
• Review team identifies need for additional expertise on committee (SGEs members or consultants). Reviewers, team leaders and division directors work to find appropriate consultants for the committee. Names are provided to DFO.
• Review team puts together background package and rehearses presentations for the meeting."

This provides a rough estimation of how long we would have waited if Thero had decided to delay the announcement.

These are irrefutable facts and have nothing to do with any biases MRC may have.