Replies to post #5498 on Dendreon Corp fka DNDNQ

[rancherho]

The FDA Priority Review rules provide a target of 6 months, the "PDUFA clock" or review cycle from the time an applicant submits a complete BLA. If you assume that the FDA accepts DNDN's corrective action plan for its manufacturing problems and appropriate stat results, a preapproval reinspection would occur during that 6 month period. CEGE's timing for a GVAX filing would also have to include the time required to prepare the BLA itself, which is no small job. DNDN's BLA was impacted by the requirement that the planned commercial production facility be ready for inspection when the BLA is filed. In DNDN's case the NJ facility was only in planning at the time of the pre-BLA meeting. CEGE apparantely completed their California production facility in 2004 at a cost "north of $50 MM" (according to their CEO). The State of California required that it be inspected each year per the same cGMP standards that the FDA uses, while NJ does not. If you assume that neither company will face further manufacturing inspection problems, a reasonable assumption might be that it might take DNDN 2 months to file an amendment to its BLA, while it could take CEGE 9 months to complete and file a BLA.Thus, DNDN could have a lead of some 7 months or so assuming equivalent clinical and manufacturing results and timing.

While not directly responsive to your question, capacity might also be a consideration wrt Provenge. Past PR's indicate that only 25% of the plant was equipped with modular clean rooms, labs and offices and 12 out of a planned 96 workstations. Gold once indicated that at capacity, the NJ facility would be capable of producing Provenge yielding $1 billion in sales. At an estimated $35,000 per patient for three doses, this would equate roughly to 30,000 patients and 90,000 doses. Obviously, DNDN would have to expand present capacity rapidly. The batch processing nature of GVAX makes it easier, cheaper and faster for CEGE to expand output.CEGE's CEO has stated, however, that their plant has ample capacity to launch commercial production. All JMHO.