1. Urdal: We will file on the 25% portion of the New Jersey Plant.

 

2. Mitch: We still expect to file the BLA in the 4th Quarter and see an Approval PDUFA date in the first HALF of 2010. (If we filed now in August, Approval would come most likely six months later--—in February. similarly September means March and October means April. So the choice of "Half" instead of "Quarter" is telling. We now can forget about an aBLA being filed earlier than long-standing guidance as many once had predicted.)

 

4. Greg: We felt fortunate to get in the Diosynth Production queue as early as we did. (One explanation why this production order is more than twice as big as the one filled in 2006 for New Jersey.)

 

5. Greg: As before, and until Approval is in hand, we will expense all money paid out for Antigen supplies from Diosynth. (My note: Incidentally, those dollars, once expensed, cannot with impunity be changed to inventory upon receipt of an Approval from the FDA.)

 

6. Mitch: As in 2006, we are filing a rolling BLA (electronically). (I hypothesized this yesterday. Now we know for certain that it is under way.)

 

7. Mitch: Once construction starts, the two new plants (in Atlanta and Orange County will require a year to build and then must be FDA inspected and Approved prior to commencing operations. Guidance is for completion of all pre-production criteria and these plants will commence shipping in the 2nd Half of 2011. (This would suggest construction starts roughly in January 2010.)

 

8. Greg: (Some already have said they think Greg said) "there will be no need to access capital markets before Approval." He did say that, but in a context quoted in full below.. Greg did not preclude accessing capital markets "before Approval." 

 

9. Urdal: In talks with FDA we have covered completely what must be in the aBLA regarding everything in the Complete Response Letter of 2007. Urdal described this meeting in May as having been very important, saying they went through each item in the CRL item by item and line by line to assure that all Dendreon efforts will fulfill in every respect the FDA expectations. (Since I now am guessing the CRL specified a Data Control Lab and a Quality Control Lab must be built, then that explains the N.J. Contractor's handsome bonus incentives for an early December completion date. It seems obvious that we cannot complete the aBLA application and start the clock running on an Approval date until the Henderson Company has earned their bonuses—or not (as the case may be).

 

10. Mitch: RestOfWorld negotiations are active. We still plan to retain entire U.S. market.

 

11. Urdal: Most of the ramp-up money is going right now for the N.J. Construction plus a $20,000 deposit on the $39,000 order from Diosynth for Anitgen inventory essential to production in all the plants (as they come on line—or expand capacity as will occur in New Jersey.)

 

12. Mitch: Analyst Day will be on September 24th in New York. Most questions on commercialization ramp-up for production and marketing are being deferred until the September meeting. Urdal stated: "In this regard, Sales Professionals are eager to join the company." Mitch: The conference will cover (1) Commercialization of Provenge, (2) plans for "the Platform" (Neuvenge, trp-p8 etc.) (3) A brief overview of the Clinical Data.

 

casey

Note on the Editing changes and Additions (mostly the latter): I was unable to re-listen before posting since the recording did not begin on time and was almost two hours late in coming on line. Now that it's up, I have below, a direct quote from Greg Schiffman in response to a Question from the Deutsch Bank representative, Robin Carnasis (sp). This quote led to a rewrite of number 8 above. Further I am adding a personal comment on the new quote at the end.

 

 

My take on this passage is that Greg is not precluding any financing action, but he is making it clear that with 200 million in the bank at the end of the year, we are self-sufficient for some time to come. Further, this, to me is saying to hedge funds, that if they need more shares from the company, then those will not come cheap—especially since we have options to secure cash without going back to the equity market well.

 

Among possible other sources of money there are as many as your imagination can provide. Number one on the imagination list, however, would be a Rest of World Partnership Agreement. Surely this is what he had in mind. But there are other private sources of capital to which he could be alluding as well. The character of Dendreon changes dramatically with an FDA Approval. If you think on it for a moment, you can see that, as a going concern, the company will haver cash flow (and profits without taxation for some time to come due to its large losses over the past 15 or so developmental years). We will have borrowing capabilities with commercial banks as well, and we will have Patent Licensing royalties that will likely increase exponentially. Without necessarily thinking to do so, he is telling the shorts that their next Dendreon shares may have to come from a stock squeeze. If nothing else, the Hedgies will have to make nice when next they come calling!