"The first stated reason for rejection—an insufficient number of patients—could presumably be rectified with data from the U.S. trial, but that trial is nearly two years from completion, so this is not an especially helpful solution."
And also the most important one. But the pharming deal you think seems like a long shot and might not put a floor on GTCB's price in the short term.
GTCB from PR "On the basis of recent conversations, GTC understands that the CHMP, after excluding data from pregnant patients, determined that an insufficient number of surgical patients were enrolled to support approval."
I'd think it would be much easier to predict when you would get pregnant patients (hence easier to recruit) than surgery patients. Seems like they raised the bar.
DEW, re:GTCB and insufficient patients, testing, and data uh are you saying the endpoint probability as to whether stuff works is open to better testing design and that scope of presentation (grab bag of flawed elements) sabatoged the project before a scientific basis for the drug could be properly analyised?
The second stated reason for rejection—insufficient immunologic data—is surprising because GTC has stated that no one among the 200 or so individuals who have received ATryn in the various clinical trials has ever shown antibodies against the drug.
This sounds an awful lot like the scientific version of "Biotech animals just scare me. I can't tell you why, they just do." The EU version of the FDA ruling on the morning after pill.