Scott,
I don't think the ODAC meeting on December 13-14 will handle things like INDs. Their agenda seems to be the following (going slightly off-topic).
Ice
"On Dec. 13, the committee will discuss new drug application Femara (letrozole) Tablets, 2.5 mg, Novartis Pharmaceuticals Corp., indicated as first-line therapy in postmenopausal women with advanced breast cancer
and histamine hydrochloride injection (1 mg/ml), Maxim
Pharmaceuticals, Inc for adjunctive use with interleukin-2
(aldesleukin) in the treatment of adult patients with advanced metastatic melanoma that has metastasized to the liver.
On Dec. 14, the committee will discuss Biologics license application, Campath, (alemtuzumab), IlexTM Oncology Services and Millenium Pharmaceuticals for the treatment of patients with chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy;
and single patient exemptions to the use of nonapproved oncology drugs and biologics". |
