one more, from the smarter child... read this 5 times before you invest in any other stock for the next 5 years
Cosmosman,
I appreciate your posting and mostly agree with your points regarding Pazdur and his biased views.
However, your posting misses or ignores the most important aspects of my analysis or intent for my posting. I posted my analysis about a week before tha panel meeting to provide an "objective" viewpoint to counter the negative tone of the message board when DNDN stock price had receded to mid 3's and short analysts were making their final negative staements regarding the advisory panel meeting. Their was a lot of concern regarding whether Provenge will be given a positive vote. The most important parts of my analysis dealt with whether Provenge will be approved or not. I provided a balanced analysis as to why Provenge would be approved. (By the way, I have received many positive e-mails about this post and many have indicated that my analysis helped convinced them to invest in DNDN beore the panel vote or affirmed their conviction to hold DNDN into the panel vote despite the negative tone of the analysts at the time.)
As I included below, my major point was that the advisory committee will find that "evidence clearly demonstrates that Provenge is safe and effective for therapy of hormone refractory PC patients". I also predicted that the panel vote will not be close and that the "vote will be between 12/3 to 10/5 in favor of approval". The actual final vote was 13 to 4 in favor- so my prediction was on the money. Another important point that I made was that "Contrary to what some have stated in this MB, patient testimonials and evidence for public support of this drug will be hugely important for approval of this drug". I think anyone that attended the panel meeting will agree that patient testimonials were critical in influencing the panel's vote.
I also predicted that "Contrary to what many have stated, I think FDA will give full approval but will require Ph 4 study to complete the follow-up analysis of the 9902b study". We will know on May 15th whether this prediction is correct or not but I stand by my prediction. Prior to my posting, I remind you that the predominant view on this board was that Ph 4 sutdy will not be required. I stand by my predictions.
I have enjoyed everyday since the panel vote and have been smiling continually and I hope same holds for other DNDN longs.
I hope you do the same and remember that 13 out of 17 voted positive. I don't mind you criticizing my view but don't forget to mention the positives as well.
We won, let's enjoy till May 15th.
I have included my summary statement.
"In summary, from my perspective as a physician and a scientist, when all the data are analyzed as a package as will be done by CBER members, I think that they will see as I do that combined evidence clearly demonstrates that Provenge is safe and effective for therapy of hormone refractory PC patients. In patients that Provenge induces immune activation, the immune system attacks the cancer cells. Additionally, when Provenge is combined with taxotere, it has a synergistic effect- this is the future of therapy for PC.
IMO, I don’t think the vote will be close, I am predicting that the vote will be between 12/3 to 10/5 in favor of approval. Having said this, I think there is about 80 % approval and 20 % approvable with completion of 9902b. Contrary to what many have stated, I think FDA will give full approval but will require Ph 4 study to complete the follow-up analysis of the 9902b study. (When ELAN’s tysabri was initially approved for multiple sclerosis therapy, FDA also required that their on-going Ph 3 be completed as a Ph 4 study for confirmatory purpose.)
Some other opinions:
I personally do not ascribe to the theory that Pazdur or ODAC members are inherently negative about vaccine therapy or Provenge- they will make their decisions on the quantity and quality of data presented balanced with the need for therapy that prolong survival without toxicity.
Contrary to what some have stated in this MB, patient testimonials and evidence for public support of this drug will be hugely important for approval of this drug. If a CBER member is on the fence about the decision or leaning against approval, it makes it much easier for him/her to approve the drug if large number of patients provide testimonial about how this drug saved their life and for patients with advanced PC to state how this drug is crucial for their survival. If FDA members know that there is a huge public support for a drug product, they are more likely to approve the drug. I would strongly encourage all interested members to show up at the meeting or write thoughtful e-mails outlining importance of this drug fro PC patients."
