$LPCN Hopefully, we won't get to this, but for reference about formal disputes: AGRX got a 3rd CRL in early 2018 for Twirla (contraceptive patch) and then pursued a formal dispute. That dispute got denied (needless to say SP went even lower on the denial and reached $0.23) , and AGRX filed another dispute higher within the FDA. Only then did FDA gave them a path forward in the form of a small adhesion study (which Co did and had good results). AGRX also requested an AdCom (not the FDA), and got 14-1 in favor of approval a few months back (when AdCom docs were clearly against approval). FDA did not want to approve their med, period! This is to show that even the formal dispute process can be convoluted, and the power of an AdCom for a med that FDA insists on rejecting on very weak grounds. I truly do not see the Cmax deficiency as strong grounds for rejection given what a few experts said during AdCom, and Jatenzo's approval with similar Cmax issues (especially the higher value).
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