(Continued from Part 1)

4. BLA Then and Now. He went on to cite the comparative numbers that are, in each statistical category, quite close to each other. In his words: “The FDA asked for more proof of efficacy. Clearly we have delivered the data.” I believe that he sees no logical way the FDA can turn us down after being given such bountiful evidence that Provenge is a viable option for late-stage AIPC patients—the focus of our Trials.

But we spent five or so minutes on idle speculation as to how logical they will see themselves needing to be in their 2010 deliberations. Lord Acton’s dictum wasn’t mentioned, but could have been, in the context of that discussion.

5. Deep Capture. He said he had read the first 7 Chapters of Deep Capture’s Dendreon Story. He plans to read more. (I am sending him Joanie’s cross-reference document from her Post #289402.) We did not give the expose’ much time since it then would have taken over the conversation. We saved that talk until after the series is complete. But I assured him it was essentially accurate as our long-term shareholders are recalling it—at least in its larger more-important particulars.

6. Partnering. I mentioned the IV Board’s on-going interest in speculating about a Partnership Agreement. (It must be noted here that all our conversations are constrained by him having to hold entirely to that which he knows already is public information. I can provide insights, opinions and even suggest future courses of action that perhaps have not been considered, but whether they are new or not is never revealed. No proprietary information is ever sent our way. Still, there are some degrees of enthusiasm or restraint in his answers that are open to interpretation. But, of course, the interpretation is only as good as the interpreter.)

So, as to the Partnership, he began by pointing out that a business partnership is very much like entering into a marriage. This is stating the obvious to me, but its order in his response seemed important. He elaborated. “Of course, the PA subject is frequently broached by interested parties (plural). But, in a marriage, there must be complete agreement between the parties (different parties but still plural). One person alone cannot make a marriage.” The emphasis he put there told me we are bargaining tough—just as Brewer and Gold had indicated at the ASM in response to floor questions.

“There must be two parties,” he continued, “who see it as absolutely the right and best thing for both to do, or no marriage will take place. We are very well situated for the next couple of years. We have all the money we reasonably can employ wisely in the business. We are building out the plant in New Jersey as rapidly as can be done. So a Partnership is something we can do equally well with or without.”

That’s paraphrased, but it’s in its proper sequence. My impression was that the Dendreon half of this marriage is in no rush to establish a marriage—especially one that might someday veer wrong, or that might not easily, productively, comfortably and profitably endure. A right deal with the right partner, one that is a great long-term fit, will be considered seriously. Anything short of that will not be so much as considered, in my view of it. It won’t be a take-over as occurred with JNJ and Scios. Dendreon will be an equal arm’s-length partner and in control of its own destiny.

7. The Build-out in New Jersey. This is why I sense no speed-up in the BLA, no rush into a Partnership Agreement, and no need for an FDA Approval decision before this time next year. But be assured that we are not behind schedule on this all-important project.

Greg cited the published Contract with the Pennsylvania Contractor as governing the time schedule. It calls for substantial bonuses for that contractor if he completes the work in April 2010. Our Execs expect that completion to be on time, barring labor or civil disorders and/or other significant delaying events. He expects “substantial completion” by the end of April next. Those words suggest minor loose ends to be attended as Dendreon readies the completed plant for FDA inspection.

The next step, once the Contractor finishes, involves the “Validation process.” It leapt to mind that this is a word we have not seen on the board since early 2007. But there it was, and it means more time must pass before FDA inspectors are invited in to do that which they must do. Greg explained that DNDN must work through the plant “after Construction is complete and Construction crews have left” to ready it in minute detail for an FDA visit. As Greg put it, “The facility must be deemed to be production ready to our satisfaction,” and then “we turn it over to the FDA (subcontractor) inspectors.

I can see that turn-over coming by mid-May, but the inspection process itself is potentially a back-and-forth activity that can consume weeks before there can be an FDA sign-off on the facility and then a decision on the License Application (the BLA).

8. Timing the BLA. I did not ask if the BLA will seek approval for the 100% built-out plant, because no answer would have been forthcoming since it is not yet public knowledge as to what will be in the BLA regarding manufacturing. But I will hypothesize that the company will seek an Approval based on one plant at full capacity being on-line.

One-plant at full capacity could easily be inadequate to meet demand once an Approval is in hand. Urologists and oncologists have been reported by management to be 94% aware of Provenge and more will know about it a year from now. It would be embarrassing to Dendreon and to the FDA if we get an Approval and immediately fall hopelessly behind demand. That potential alone could delay an Approval (as can Manufacturing fine-tuning for CMC issues).

So the BLA must be perfect when it goes in—down to the last comma. So also must the manufacturing capability be not only perfectly constructed, but it must be reasonably adequate to the task. Therefore, the BLA does not need to be submitted before 4^th Q 2009—and, in my view, not much before December. In truth, it would be unwise and impractical to rush this process. Speed is the wrong priority here. (Yet the fact of dying patients argues the opposite. Emotionally, we know we should rush. But, if in the rush we fail, how far more tragic that would be!) We know that with a short 6-month FDA PDUFA date, inspectors theoretically could show up while the Contractor is still on the premises—even if DNDN delays the BLA until a December filing date. These things must be exquisitely timed.

Plant capacity will be an issue—even if an unspoken one. But a plant with 48 Units up and running (96 work-stations staffed and operational) is the minimum number I believe the company decided (after 2007) to have in the Biologics License Application mix. To have done otherwise almost certainly would have been to invite further trouble IMO.

9. In summation. Mr. Schiffman has been both gracious and generous in addressing these many matters to the extent his position and the SEC allows. I did not raise the matter of the upcoming wrap-up on the IMPACT Trial when the 360-event data are in hand. Neither of us is schooled in Statistics, but we know that these new data are coming in the next 4 to 8 weeks and, if like all the other IMPACT data, should, as croumagnon wrote today, fire the stock to higher levels.

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