Replies to post #4681 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Is 44% not statistically significant??? Am I missing something here?<

The French study cited by ‘vinmantoo’ was a tiny trial (n=35 ITT, n=32 PP) that lacked the statistical power to detect a survival benefit because the number of deaths in each of the trial arms was too small. This is also likely to be the case in Leo Pharma’s phase-2 DIC trial with about 200 patients—it will be powered to show a successful resolution of DIC but not a survival benefit. (The phase-3 trials to be run by Leo and GTC will be powered to show a survival benefit.)

On the endpoint of DIC cure, the small French study was statistically significant, showing a 71% cure rate in the AT arm vs a 33% cure rate in the control arm.