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Re: AVII77 post# 163595

Wednesday, 11/28/2018 1:05:29 PM

Wednesday, November 28, 2018 1:05:29 PM

Post# of 447305

Is it possible that we are not submitting a sNDA? But rather a response to a CRL from a previous sNDA (ANCHOR)?



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had 1 yr to respond with the requested additional info, and if it was not received in time the sNDA would be considered withdrawn (AMNR may have had option to ask for short extension, but they didn't, no point).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.

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