re: CLDX
BTH,
I don't think that Mariucci will sign a bad deal for 011. He seems pretty savvy and he does have the experience at Medarex and the BMY deal.
CLDX would like to do a single-arm study in "high-expressors" with a relatively small patient population, 150 patients, to gain approval, but they haven't gotten the go-ahead from the FDA for this. CLDX may have to do a randomized study with 400 patients, if the FDA won't sign off on the smaller, single-arm study. The Phase III will start in the 2nd or 3rd quarter of 2013, in any case.
Discussions are ongoing with potential partners for 011. The prospective partners do not need to see the data to be presented at SABC in December to finalize a partnership.
Management said that they do not consider Avastin a competitor in glioblastoma. At some much later point, they expect to do combo studies with Avastin.
Results with CDX-1401 will report in the 4th quarter.
Results with CDX-1127 will report in solid tumors in the 4th quarter; in hematological malignancies in the 1st quarter of 2013.
Bladerunner