Biotech Values

[poorgradstudent]

DNDN:

>Survival was stat sign and TTP was about .084 or .054 after some errors were corrected on audit. For want of .004 you say the null hypothesis wins? That seems awfully pedantic. <

For the two trials:

Survival was 0.01 versus 0.331.

TTP was 0.084 (as per briefing doc) versus 0.719.

Those numbers don't look to me like they are consistent at all, even if you change 01 TTP to 0.054. Not one of the additional analyses (TTP confirmed by imaging, time to disease related pain progression, time to clinical progression, time to treatment failure) reached stat sig. An objective response in the phase I/II experience (~70 patients) couldn't be reproduced in the treated 01 / 02A / P-11 patients (~220 of them).

I'm not trying to be pedantic, but we either have standards or we don't. It is not DNDN's fault in any way, but merely an FDA issue. If this BLA gets approved, the standards are out the window imo.