1. Dave Urdal made it absolutely clear in responding to David Miller's question that only the existing 25% part of the NJ facility will be inspected by the FDA as a part of the BLA evaluation. They will host another inspection for the other 75% being built out after it is completed.

2. Schiffman said that there won't be need for another financing deal until after the FDA response. He might have let it slip that a substantial partnership deal is close when he said something to the effect that they might not need to go to the financing route to advance the marketing of Provenge and the pipeline.

3. They had a meeting with the FDA in May about the process to amend the BLA. The main assurance from the FDA was that the current data from IMPACT is sufficient for licensure. This is fairly standard procedure but, in a separate discussion, Jennifer Williams confirmed that the entire Statistical Analysis Plan, ie, all needed sensitivity analysis, were discussed with the FDA and agreed upon by both sides before the trial was unblined in April.

It appears that both efficacy data and manufacturing capacity are in order for a smooth evaluation by the FDA. Let's hope so.