Replies to post #122973 on Biotech Values

[DewDiligence]

Thanks, Idit, but you didn’t answer oc631’s question about whether the FDA will entertain an early NDA submission—i.e. a submission based on phase-2 data—for the genotype-2/3 subgroup.

[oc631]

Perhaps I should have emphasized the word cure in #msg-61679544 :) I really cannot guess what will be the FDA' position regarding early filing, but I do expect good 24-week SVR data from that trial and even see a reasonable chance for monotherapy to work in GT2/3 patients.

VRUS added a 8-week GT2/GT3 treatment arm to the ELECTRON study using the 400mg dose. If all treatable patients in this study achieve an RVR at 4 weeks, which was previously demonstrated in PROTON, and an SVR at 8 weeks this would reduce the time patients need to be on interferon by 16 weeks (current SOC for GT2/GT3 patients is 24 weeks of Peg/Riba). An advancement of this magnitude deserves to be brought to market early if PSI-7977 continues to prove safe and tolerable across all studies come November.