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Re: cysonic post# 27778

Tuesday, 06/13/2017 1:31:10 PM

Tuesday, June 13, 2017 1:31:10 PM

Post# of 38634

Apart from that, the most important date still is September 25, 2017 (or an AdCom before).

It is fact that in a case where there is a lawsuit pending... the FDA does in fact diligently work on the approval process... and come the PDUFA date, IPCI will either receive a CRL or "TENTATIVE APPROVAL" which becomes a full approval once litigation is settled... which may be as late as 30 months or as soon as the lawsuit is deemed invalid... or a settlement agreed to by both parties.