6. I still believe that Dr. Raj Puri of CBER, who has been involved with DNDN since the beginning, will probably be the lead FDA doc. The CTGT panel’s Chair, Dr Mule’, an oncologist and immunologist, who, I believe, worked at the FDA at the time of DNDN’s initial Ph 1 trial, will remain and may have a substantial say in the appointment of any temporary members.
These are safe assumptions. Puri is the the Director of the Tumor Vaccine Division so it would be mighty strange if he is not directly involved in the first vaccine to come up for approval. I was told that the CTGTC was recently renewed for another two year term. Mule' is still listed as its Chair.
