Replies to post #10710 on GTC Biotherapeutics (fka GTCB)

[kris_kade]

Well, if you take into account the GTCB fatcats' vacations to bermuda, they are doing best they can..LOL

[DewDiligence]

>why BLA filing is delayed until July/August?<

The guidance on yesterday’s CC was for a submission in late July; my post says Jul/Aug to allow for a little slippage.

>Moreover for clinical, hardly 32 patients are in the study. Summarizing 32 patients data is not same as thousands of patients. With huge cash burn rate, shouldn't his management hurry up with these things?<

Well, it’s better to get things right than to rush the BLA and end up with an approvable letter instead of an approval. I don’t know why the analysis can’t be completed sooner, but it may have to do with the unorthodox trial design, which includes a blinded, historical control arm. Regards, Dew

p.s. The total number of patients in the trial including the control arm is 68 (17+14+37).