Dendreon (DNDN-NASDAQ) spoke on a planned conference call this evening that was moved to 6:30 PM EST rather than the 7:30 PM EST planned time.  They probably had a major steak dinner and 12 cases of champagne to get to.  I know I would if I was them.  This was on the favorable outcome out of the FDA Panel Review for its Provenge(R) for the late stage patients suffering from advanced prostate cancer.  The company noted the evidence of safety and efficacy, and Provenge will provide the treatment that extends survival t these patients.  Dendreon says will be working with FDA and the PDUFA day is currently May 15.  Please pardon the lack of names because it was hard to tell who was speaking inside the company to analysts.

We note here the name of the firm asking the question, and then we have noted the questions with the answers.  This was taken in notation format since it was a summary, so you will have to see the “question” or “ask” and then get the answer that follows it.  Here goes:

JMP Securities analyst:  As far as commercial plans and launch here and abroad?   
The company said that they can launch it themselves here.  They expecta decision by May 15 PDUFA date and will go from there.  The otherstudy is 400 patients enrolled.  As far as looking at this in modelsfor number of patients???? The company noted it is 98,600 men and thereare 50,00 in the target in the US; in Europe they think it is similarbut it isn’t known in Asia.  As far as “additional data submissions” onmanufacturing???? They had the FDA inspect the facilities and they arestill being discussed before PDUFA date.  Analyst admitted he had somechampagne, funny and then asked about sales force:  the company saidthey can handle 125 individuals and they can manage it.

Biotech Stock Research (David Miller), newsletter writer that has beenpositive on DNDN:  As far as when they are pulling the trigger, butthey didn’t really say much.  As far as giving thought to “FDA sayinggo ahead and marketing”?? They are completing the “IIb study” and arestill discussing with the FDA.  Is there a chance for a label of “forCaucasians only”?  The co. says they are discussing that with the FDAbut they don’t see a difference biologically in prostate cancer.Company says enrolling minorities had similar profile but admitteddifficulties.  On the Shelf Registration and Timing?  The company saidit is preliminary to talk specifics but they said as they get morefeedback that they WILL require additional funds.  (For conjecture, itwas hard to tell if the company meant they would wait until the PDUFAdate of May 15 before they announce a share sale or if they would do itsooner)

NEEDHAM Analyst:  With 400 patients enrolled in the IIb, do they knowwhen they will see more results?  The company is maintaining again theywill complete enrollment.  The company would not predict the exact outcome, but the FDA has so fargiven the right indications and the patient community was clear inwanting a new treatment.  As far as what the answers WILL and CAN befrom FDA: company is pleased today but won’t predict the outcome.  InNew Jersey plant how many patients can they treat:  they still don’tknow until the FDA PDUFA.

Bank of America analyst:  As far as panel members and association withpolitics inside FDA…company won’t comment there on politics insideFDA.  (it sounded like company is working with the more favorablegroup, or so they inferred)

UBS analyst:  As far as numbers of enrollments inside impact studyseeming less than 200 in Provenge arm and 100 in placebo group? The co.said the actual number was 400 patients and that wasn’t shown in aslide.  The will show 360 death events the estimate to show by or in2010.  The company won’t show a pre-specified look at IIb results.

Lazard substitute analyst:  What is the risk that PDUFA date decisionwill be different because of different dates?  Company said the wordingwas changed by FDA and any confusions were from the wording the FDAused.  The company won’t speculate as far as certain outcome, but againsaid FDA usually follows its panel recommendation.

McAdams Wright Ragen analyst:  On the FDA meeting being 8 hours longand an indication of what got them over the goal line to panelbacking?  Co. says the presenting team did a great job and they madethis happen.  The survival data carried the most weight AND thecomments from the patient group made a huge difference.   As far as FDAmeetings ahead and guidance on cash burn?  The company will update thatas they know more.  Question on whether investors should watch for mostpertinent news out of the company or out of the FDA?  The company saysthey will communicate the bulk of the data and they try to keep that upas they have been a constant communicator.

Lazard (main) analyst:   As far as questions the panel asked inefficacies?  The company said the first was 17-0 and the second was13-4 and there may have been some difficulty in interpreting thequestion.  Will the FDA ask additional questions or differentquestions? The company doesn’t know why they would but they won’tpredict.  On interim II study? The company will look at those and makethem available when they have it.

The CEO said this was a historic day for prostate cancer patients andfor the company.  As far as our comment on this: “Yeah, you can saythat again.”

CONJECTURE:  As far as any conjecture on analyzing how the company didon their answers, this is fairly easy.  I re-listened to the conferencecall to make sure on this, but all in all the company handledeverything they could quite well.  They were very straight and to thepoint on most of these, even though some of these answers wererepetitive.  There were not any classic tells shown of lying or highlyselective omissions made by management.  There is obviously not ariskless transaction, because there never is.  But all in all it sureseems like the company and the community would seem to agree that thisPDUFA date of May 15 will go in favor of the company.  Is that anassurance?  No way.  The FDA does some strange things sometimes, andlately they seem more and more that way.  Prostate cancer patients havemore likely than not just made a new friend, and because of that thereare some pretty happy investors today.  Be sure to watch out for asecondary offering at some point, because while the company did put that off a bitthey did say that they will need more cash to ramp everything up toproceed.  And companies can change their stance quite rapidly, particularly if they get a massive jump in their stock prices.  Watch out for this one tomorrow, because with the 200,000 to 300,000 of near months’ expirations (April & May) open interest and the massive short interest of more than 30% of the float this one is going to be wild Friday.  Does window dressing matter for that day? Maybe.  Dendreon (DNDN) shares did not reopen today, so the trading will resume Friday.  There is a chance that you can track this on Friday much earlier than would normally be available because the stock does actually trade in Germany under the "DNR" ticker in Frankfurt, BUT you will have to verify all that data and pricing for accuracy since almost everyone in the U.S. has delayed quotes for Germany.  OK, it’s been a 15 hour day on the desk, so good night….. and congratulations to Dendreon and to advanced prostate cancer patients hoping for one more possible treatment.

Jon C. Ogg
March 29, 2007

Jon Ogg can be reached at [email protected]; he does not own securities in the companies he covers.

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