Amarin Corp Plc (AMRN)

[Atom0aks]

FDA has repeatedly shown they can and will ignore guidelines (they're not legally binding) when it comes to AMRN. They'll delay as long as they damn well please and AMRN has no legal recourse.

Got a source, chief? Or at the very least give me any example of a company that got an extension longer than three months.

And I don't believe FDA can issue a CRL because the AGENCY has internal problems, i.e. organizing and staffing an AC - CRLs are issued for drug apps that are not approvable in their current state, and requires the whole sNDA process to start over again once the deficiencies are addressed.

Here are possible reasons for an advisory committee:

4.7.1 Advisory Committee (AC) Meetings
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.

Source: https://www.fda.gov/media/78941/download

Here is the procedure for a CRL:

(a) Complete response letter. FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form for one or more of the reasons given in 314.125 or 314.127, respectively.

Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.110

Here is section 314.125: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.125

Here is section 314.127: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.127

You will notice the reasons given in those sections are similar to the reasons for an advisory committee. One of those reasons currently motivates the FDA to hold an AdCom. Therefore, if those reasons cannot be addressed, either by AdCom or an amendment, within the time limits provided by the review guidelines, those reasons could easily be used to justify a CRL. Make sense?