Dendreon Corp fka DNDNQ

[rancherho]

Composition of the FDA’s CBER Cellular, Tissue, and Gene Therapy (CTGT) Advisory Committee

1. DNDN’s Dr. Provost made a presentation on DNDN’s CD54 potency QA release marker to the presently constituted CTGT Advisory Committee on 2/9/06, which a review of the Transcript seemed very well received.See: FDA link to 2/9/06 presentation of DNDN’s Dr. Nicole Provost to CBER’s Cellular, Tissue and Gene Therapies Advisory Committee (Transcript and Slides)http://www.fda.gov/ohrms/dockets/ac/cber06.html#BloodProducts

2. In 9/05 post the FDA / DNDN pre-BLA meeting, Gold mentioned the possibility of a hybrid Advisory Panel. Considering that Provenge will be the first therapeutic cancer vaccine coming before an Advisory Panel, IMO, the likelihood of a hybrid Advisory Panel where oncologists and possible immunologists would replace the members of the Advisory Committee who really are not experts in the relevant specialties is great.

3. Look at the composition of the Cellular, Tissue and Gene Therapies Advisory Committee at: http://www.fda.gov/cber/advisory/ctgt/ctgtmembers.htm

4. Six members have immunology (IM), oncology (ONC) or biostatistics (STAT) experience relevant to Provenge’s BLA: (a) Dr. Mule’ (IM, ONC). (b) Dr. Kwak (ONC), (c) Dr.Urba (ONC), (d) Dr. Gerson (ONC), (f) Dr. Chappell (STAT), and the non-voting industry rep, Dr.Gunter (Cellular Therapy).

5. 8 members really do not have relevant ONC, IM or Cellular Therapy expertise: (a) Dr. Allen (Veterinary), (b) Dr. Calos (BIO/GENETICS), (c) Dr. Taylor (Cardiovascular), (d) Dr. Guilak (Orthopedics), (e) Dr. Tomford (Orthopedics), (e) Dr. Chamberlain (Gene Therapy), (f) Dr. Woo (Gene Therapy), and (g) Sharon Terry (Genetics) non-voting consumer rep.

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. The FDA may go to Dr. Pazdur of CDER, however, to nominate substitute members. FDA Chief von Eschenbach might also appoint some NCI immunologists / oncologists as temporary members.

7. In any event, the composition of the Advisory Committee members will be quite important given the importance of receiving a strong endorsement prior on any final FDA approval and the resulting effect of such endorsement to DNDN’s ability to raise launch funds at attractive rates. The timing of a Provenge Advisory Committee meeting and the designation of its composition will probably depend on the pre-BLA FDA inspection of the DNDN NJ facility going on now, and completion of the BLA.

8. Does anyone have any inputs on if and how previous temporary hybrid Advisory Panels were handled?

Good luck to all DNDN longs.