Replies to post #33251 on Amarin Corp Plc (AMRN)

[BioChica]

Exactly! What point would there be to modify SPA(Contract for Study design) after the fact. A label change would be appropriate!

[sts66]

I agree no change to SPA makes sense, the only thing relevant is "you can file sNDA for ANCHOR after 50% enrollment of R-IT" - what the FDA likely wanted to change was language for ANCHOR label, which AMRN may have refused. If FDA said "no ANCHOR until interim R-IT results", of course AMRN would have refused, as they needed the cash to get there.