Biotech Values

[p3analyze]

>> KM curves the PFS curves are already very mature.<<

I would agree if sample size were big. Have you tried to stress test this theory by imputing different PFS time for the 5 censored subjects in he TN group?

Nice work on the HR calculation. Did the risk set match up against the denominator (after adding back those that were excluded)?

>>lowest threshold of ORR<<
This is where an oral ASCO abstract session would have helped, and I suspect CLDX is convening some experts to answer this question. I have a feeling FDA may be able to live with lower ORR hurdle for smaller patient population with more dire unmet medical need.
Whether FDA needs confirmed ORR is hard to tell. I am not aware of any precedents of approval based on unconfirmed ORR. It is an option given to the investigator in the new RECIST 1.1 but the RECIST working group leave it up to the sponsor and FDA to decide whether confirmation is needed.