Amarin Corp Plc (AMRN)

[Biobillionair]

One major deficiency in current FDA regulations is the complete lack of timeline relating to delivering CRL. Amarin's PDUFA date is on "hold" with the "sNDA still pending"...This gives the FDA the regulatory right to delay forever.

After one year

FDA may consider an applicant's failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application

No Regulatory timeline on waiting for CRL?

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