Dendreon Corp fka DNDNQ

[walldiver]

Discussion with DNDN CFO, from plotinus4me over at I-Village:
http://www1.investorvillage.com/smbd.asp?mb=971&pt=msg&mn=155701

Msg: 155701 of 155704 9/14/2007 1:34:45 AM Recs: 6 Sentiment: Strong Buy
By: plotinus4me Send PM Profile Ignore Recommend Add To Favorites

Thoughts on recent posts and discussion with Greg Schiffman 9/13/07

On every MB for every stock, you will inevitably find posters who are down on the management. It doesn't matter what industry, it doesn't matter whether the stock is up or down (although one finds these malcontents most often with stocks whose price has fallen or whose price hasn't gone up much over a period of time), there just seem to be dissatisfaction with the CEO, CFO, and/or IR. Check it out for yourself. I follow a number of stocks and am always looking for new ones to invest in, and sure enough there are the posters with a grievance.

DNDN is saddled with its detractors. Most love the science but can't stand Dr. Gold, Monique (who has now left the company, sadly for me), and there have been others. I haven't posted much since May 9 as there really hasn't been much to discuss. I have felt that management had done what they could to get Provenge approved and are now doing what they can, as fast as they can, to go for the approval again. After the positive Panel, it has been clear to me as it has been to many others, the fault for Provenge not getting approved could be laid to the CDER/ODAC side of the FDA. Possibly there was some complicity at CBER and possibly on a higher level, but the letters of Scher, Hussain, and Flemming were clear where the initial problem lay.

Now some think that DNDN did a poor job at the Panel meeting, but the results were overwhelmingly positive, so the DNDN people who presented there along with the BLA details, were good enough. Yes, it needed a phrase revision re the efficacy, but that was resolved.

Maybe someone else posting on the MB could have done better over the years or after the FDA decision, but I doubt it. I have been an avid reader of the posts over the last @3 years on Yahoo, IV and IHub. There have been some terrific posts by some really knowledgible people. But I don't think I have seen anyone's posts who could have done as good a job as the DNDN management breaking new ground re the immunotherapy field with a revolutionary new concept, adapting to changes in the way patients responded, and working with the FDA to provide a compatible BLA that should have been approved, set up a viable 157,000 sq. ft. facility in about one year for the production of Provenge, get the antigen supply approved and on stream with Diosynth, get sufficient funding (albeit with a rather ineffective approach- this now seems to have improved with the new CFO), get the BLA sent to the FDA with the first computerized submission of any company, get the CMC and BLA reviewed with priority, and then the positive Panel along with presentations at conferences and publications, and so many other things.

Frankly, anyone long this stock over the last 3 years should be looking at management as doing a very good job versus the lousy and perfidious job done by the FDA. I have great admiration for KDD, AMMASS, Yarbonero/ Mr. Serious, cben, walldiver, rancherho, ocyan, clarkster, and all of the many people who have spent incredible hours to refute the Scher, Hussain, Pazdur, Cancer Letter, analysts, and others initially after the May 9 decision and now with the demonstrations and the lawsuit against the FDA, et.al.

I have given how I feel about this and there are many, I'm sure, who will disagree with me. Such is life.

Now I am going to tell you of my discussion with DNDN's CFO Greg Schiffman (GS) on Thurs., Sept 13, 2007.

I met with GS briefly, along with some others, at the ASM. I knew he wouldn't remember me by name, but he remembered that I had used the word "Pazdurized" to reflect my disgust of the one man I felt had done so much to hurt a new field of cancer research as well as subvert an FDA approval for a drug which would helped many men with PC. He did remember that part.

Below are my impressions and understandings of my discussion with GS. As I was hurriedly writing down notes of our discussion, it is hoped that my notes are accurate. I have tried to put the discussion in a way that is more readible. Please understand that GS was very detailed in his answers and I have tried to capture the key points and substance of his answers. I hope I have not misrepresented his points in any way.

Ques: Why hasn't DNDN set up operations in a foreign country that has easier entry to providing Provenge to patients? For example, one that would recognize that the safety/efficacy re 9901/9902a and the Panel recommendation should have been sufficient for FDA approval. A smaller, NJ type plant could be established, possibly through an already established, approved facility. Presumably there would be leukopharesis facilities available in the area or easily set up. Countries that I suggested were: Dubai (as per Casey), Israel, Norway. and Thailand. There shouldn't be any problem with the FDA as companies are doing this all of the time.

Ans: DNDN had priorities. First, we had to find out what the FDA wanted from us re the BLA and then the trial data. This had to be determined and this has been done. Secondly, the plan of action had to be commensurate with our finances. Now that we have resolved these issues, we are able to look at other possibilities.

It is important to understand that many countries determine whether they will approve certain drugs based on U.S. and European approval. There are a number who do not but there may be certain qualifications to be considered. DNDN is evaluating a wide range of options and there is nothing specific at this time. But DNDN has been active in this area.

Ques: When should we hear news on 9902B full enrollment?

Ans: At this time, DNDN is no longer accepting applications for pre-enrollment. Enrollment is before the first infusion is given (either placebo or shot).

DNDN will announce when there is full enrollment. Guidance is for the 4th quarter of 2007.

Ques: How many employees are there at this time and I noticed that there are some new job openings?

Ans: There are about 200 employees and the new hires are based on specific needs of the company.

Ques: Will there be an announcment when the NJ plant 483 issues are resolved with the FDA? Any time frame? How could they be doing Provenge for 9902b if there was an FDA issue?

Before I go into the ans. on this, I want to say I have tried to understand and write the subtleties of GS's answer as best as I can. There are some on this MB that are far more knowledgible about this subject than I am and it might be helpful for these people to contact DNDN to confirm or amplify my notes on this.


Ans: When the NJ plant was inspected re the CMC, the FDA issued some feedback, ie., 483s. The 483s are not the same as the CMC. The person who oversaw the inspections was the one who was available to discuss the CMC and the 483 issues prior to (or during?) the Panel meeting. The CMC was available at the time of the Panel (AC). There were no issues that arose to a point which was "rate limiting" (AND THIS IS THE IMPORTANT POINT) and there was nothing material in the 483s that would have affected getting product approval. The CMC and the 483 issues were done at different times, both were part of the "approvable" letter. Apparently there needed to be some further discussion with the FDA on these issues at the time (as per my understanding).

Follow-on question: How could the NJ plant produce Provenge for the 9902B trial if there was a problem with the FDA with regard to the facilities or re the CMC?

Ans: There was nothing re the 483s to restrict doing Provenge for the 9902B trial. However, the plant could not produce Provenge for commercial quantities.

Follow-on question: When will the 483 issues be resolved, ie., when will there be a "pre-approved re-inspection"?

Ans: The FDA itself will give no formal documentation until the application is updated. There will be another inspection and the results will be part of the re-submission of the amended BLA filing.

Ques: Is Dr. Small still working with DNDN and in what capacity? Who is the lead researcher re 9902B?

Ans: Dr. Small's center is one of many re 9902B. He was the lead researcher on 9901. He is not the principal researcher on 9902B. He could not say who was. The main point is that Dr. Small is still associated with Provenge (which is what Monique told me at the ASM and which I reported on the MB a while ago).

Ques: What about finding a partner for Neuvenge which has several possible cancers that could be addressed?

Ans: Most potential partners are looking for advanced Phase trial results. Their first choice would be Provenge. He had no specific comments at this time whether there was any interest in Neuvenge re partnerships or with Provenge. They have had a number of prospects which they are evaluating was my understanding.

Ques: Could he comment on the efforts made re the law suit or the demonstrations?

Ans: GS could only answer regarding advocacy groups in general. He could understand their frustration. He and DNDN could not comment in any way. However, given the time frame of the mid 2nd half of 2008 when the interim look should occur, he wasn't sure whether they could speed up any time re FDA consideration or not. Basically, DNDN can't comment on such matters and I am sure everyone should be able to understand why they cannot.

Conclusions:

I found GS to be open, informative, and really helpful in my seeing the difficulties management has been faced with the "approvable" decision by the FDA. I believe that they have not been issuing a lot of press releases as their efforts have been directed toward getting the 9902B trial enrolled, getting the financing, resolving FDA issues, evaluating partnership and foreign opportunities, and moving forward as quickly as possible to make DNDN a viable player in the cancer arena.

For myself, I have been in and out of DNDN since May 9 on a trading basis. I am currently about 2/3rds the position I had before 5/9. Barring bad news or a technical aberration to the downside, I am looking to build my position. While I do not hold out much hope that the FDA will see the light and give a conditional approval to Provenge, I am hoping for DNDN to look outside the U.S. for additional opportunities.