Dendreon Corp fka DNDNQ

[ocyanblue]

CBER vs CDER.

It would be a big surprise if CDER ends up reviewing the BLA instead of CBER. Thus far, all communication with the FDA was with CBER. This included the presentation of the CD54 data at the meeting of the CBER CTGT Advisory committee on how to measure potency of biologics. In the same presentation, Dr. Provost thanked certain FDA personnels in CBER for ongoing collaboration to clarify the measurement process. Lastly, the OCTGT has an entire division and a branch in it, both headed by Dr. Puri, dealing with tumor vaccines. It would be a slap on the face to the OCTGT if somehow the review of Provenge be wretched from them and given to the CDER Office of Oncology. There is no way that any FDA chief would allow such a fracas between CBER and CDER.

Also, Dr. Silvana Martino is no longer listed as a member of ODAC. She was the Acting Chair in March when Gemzar was reviewed. Maybe she left when their recommendation was overturned. The tide is turning.

http://www.fda.gov/cder/audiences/acspage/oncologicroster1.htm