Replies to post #30571 on Cytodyn Inc (CYDY)

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“Given these promising data (92% responder rate), we plan to submit a pivotal monotherapy trial protocol for PRO 140 as a single-agent maintenance therapy before the end of 2018 with the intention of filing for a label expansion subject to combination therapy’s first approval,” explained Pourhassan.

We tend to talk about mono as all or nothing, but I feel with these results a label expansion will happen, with the low bar at combo expanding from MDR 2 patients to all HARRT and the high bar expansion into mono. These numbers are hiv patients in the US and should be reduced by 70% for r5 eligible, but to get an idea of the market increase with the expansion, again the low bar is looking like a 3x increase from first combo approval.