Here is What I Hear. Nothing major-- seems to be the same as what others are reporting.
Approximately 4-6 IST trials will have started by mid summer. Patient populations will range from 10 to 40. Investigators are eager to make a name for themselves and their clinic so we can expect to see a race for who is first to release interim data. Expect interim data to start coming out in Dec 2010 and continue actively throughout 2011.
All appearances are that Bavi performs as well as or better than Avastin.
On HIV work, the Company’s collaborators are getting very close to having a “viable delivery modality.” Lots of progress has been made with both microbicide and aerosol delivery. I.V. infusion of drugs is standard practice in the cancer community, but in the anti-viral arena I.V. delivery is not desirable. Given the huge progress made in past year on aerosol and microbicide delivery technologies for large molecules, preparations have started with collaborators for first Bavi HIV clinical trials. [No indication given on start date for HIV trials.]
Dr. Garnick is actively working on an Animal Rule application to FDA. “Rob is excited to be working on this -- an Animal Rule NDA is probably the only type of application to FDA Rob has never done before.”
TMTI work is going very well. In active discussions with government to enlarge scope of work.
Regarding Avid BioSimilars, big P.R. is “coming soon” that will layout parameters of whole program, including for example info. on how much of the BioSimilars program will be dedicated to making the Company’s own proprietary products versus how much of program will be dedicated to manufacturing BioSimilars for third parties. Passage of Health Care Bill definitely helped to accelerate this program.
