GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: US ATryn trial

>I am guessing all patients have been treated.<

If not, they are presumably waiting for the last one or two patients (of the total of 17 new patients) to be treated.

>How long after treatment are they observed?<

Patients are observed for three months to collect data on antibodies to ATryn. (No antibodies to ATryn are expected inasmuch as none of the hundreds of patients treated with ATryn to date in various clinical studies has ever shown any.) However, the antibody data will be furnished to the FDA in 2008 and are not considered part of the “top line” results to be reported any day.

How long are patients observed other than to collect antibody data? The short answer is: until the risk of the procedure in question has abated. This is an excerpt from an old post on the subject (#msg-6632420, emphasis added):

“The study will test the efficacy of recombinant human antithrombin by infusing rh AT prior to, during and following the period of risk or surgical procedure.”

Regards, Dew