Replies to post #4764 on GTC Biotherapeutics (fka GTCB)

[shears]

Will it cause me to sell any GTCB shares, phase 2b or not 2b?

That is the question.

I guess I would be a bit more sensitive to this kind of challenge if I owned as many shares as you, Noble Dew.

[floblu14]

>it’s premature, IMO, to write off ART-123 just yet<

2b succinct (thanks shears):

Since I'm infatuated with Sweetheart, I wrote it off :-)

The ART -1 investors are NOT happy puppies -

[exwannabe]

At N=50 (in the subgroup), the lack of stat sig. mortality is not surpising, but the overall DIC benifit looked promising.

Question, since ART-123 works on the APC pathway would this be expected to behave similarly to Xigris (recmbinant APC)?

[nivasvs]

The point everyone missing from this study is that, it was never meant to prove ART-123 superiority to heparin. The study was designed to show 'NON-INFERIORITY' to 'HEPARIN' and the sample size was calculated accordingly.

"As representative underlying diseases for DIC, we selected hematologic malignancy and infection. The sample size necessary to ascertain non-inferiority to heparin , without qualitative interaction between underlying disease and drug, was calculated for each underlying disease, and one verification study was conducted . All analyses were performed in accordance with a predefined analysis plan. The primary endpoint, DIC resolution rate, was analyzed among the full analysis set (FAS). Safety was analyzed among patients in whom study drug was infused at least once"