Replies to post #343 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Thanks for the JAMA link. Given the newfound importance of the DIC indication to GTC’s prospects, this article should be obligatory reading.

[DewDiligence]

>I am also encouraged by fact ATIII is already used in [DIC] in many places where it is more readily available<

In Japan, DIC is an approved on-label indication for plasma-derived antithrombin.

[DewDiligence]

A minor semantic matter re the KyberSept data:

>the statistically significant finding in the no-heparin group<

Because there were two data looks (28 days and 90 days) and two subgroups (heparin and no-heparin), I refrain from calling the 90-day results in the KyberSept no-heparin subgroup “statistically significant” even though the p-value was less than 0.05.

Given an aggregate alpha of 0.05 and two data looks on each of two subgroups, the p-value threshold for statistical significance of a single subgroup at a single data look is 0.0125, and that threshold was not met.

The above is academic, of course. The real issue is whether the data warrant further clinical development, and GTC and Leo have decided that they do.