Replies to post #163725 on Amarin Corp Plc (AMRN)

[marzan]

No the control states submit the efficacy evidence from the Reduce It trail . FDA knows the trial takes more than a year to complete. AVII might have a better response to you with proofs.

[AVII77]

No. ANCHOR is dead. CRL said AMRN had 1 yr to respond with the requested additional info, and if it was not received in time the sNDA would be considered withdrawn (AMNR may have had option to ask for short extension, but they didn't, no point). I have the CRL PDF stashed somewhere, but don't need to find it and look it up - that 1 yr timeline stuck out like a sore thumb, impossible to forget.

STS, thanks but I really think your memory on this point may be faulty.

Many resubmissions occur after a year, it would be arbitrary and capricious for the FDA to impose something like that on Amarin.

Many drugs are approved after their second (or later) review cycle and are more than a year from the CRL.

I think it more likely the 1 year reference you recall relates to how long they had to file a complaint (push it up the chain). And they did that (IIRC) a couple times.

I sure would love to see that CRL. I'll have to check my other computer to see if I saved it (it was shared on IV 3 years ago).