Replies to post #1487 on Dendreon Corp fka DNDNQ

[poorgradstudent]

Rancherho:

For #1:

>... rules out the simple expedient of increasing the number of doses over time to increase the cumulative treatment effect in terms of numbers of antigen primed CD8 effector T cells and their resulting in vivo persistence. <

Data talk. Forget all the theoreticals. I'm simply building on your claim that DNDN can just go back and do another round of drug prep from the patient to easily deal with upregulation. Provenge is easy on the patient, and the burden of preparing an additional dose would not be great in exchange for the increased HR. So if things are as easy as you suggest, then why have they not done it?

It's really as simply as that. If a company knows that a simple adjustment will increase their HR significantly, then they would do it. That they haven't done it suggests that you would do well to rethink your claims regarding CD54 upregulation.

>Please explain how and why you would further modify the 9902b trial to satisfy your statistical curiousity<

Absolutely nothing to do with statistical curiosity. Where did I say as such?

Again, it's very simple. DNDN serves its investors best by designing and running trials that stand to make the largest positive demonstration of Provenge's efficacy. If the CD54 upregulation is easily addressed by sending the patient back for another round as you suggest, then don't you think the apparent increase in HR is worth it?

Wouldn't you, as a DNDN investor, rather pursue a strategy that leads to a higher HR, based on your phase III dataset?

>while many AIPC patients would have shortened lives while awaiting its outcome.<

Nice try. Way to load the issue. Three points:

1) If, as you hope, Provenge will be approved based on 9901 + 02A, then where is the delay?

2) As I outlined yesterday, it is clear to most reasonable people that at the time that DNDN had the data, they were not far along in their enrollment of 9902B. The median survival almost doubles, and the k-m curves are clearly far apart throughout the plot... you could easily orphan the enrollees as of end of 05 and fire up the new trial with less target enrollment than 9902B due to the higher drug effect.

3) To throw the irrelevant qualifier back at you, don't you think patients are best saved from shortened lives by being offered a method of treatment that the company reasonably believes would increase efficacy versus their currently used strategy? Do PC patients not deserve a treatment that offers an HR > 2 over one that offers and HR of ~1.5?

(I expect no answer to 3. It is simply to show that your reference to patient suffering goes both ways, and loads the discussion unnecessarily.)

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As far as 9902B enrollment, I think your reference to Natexis and their "215 9902b enrollees on 2/05" really muddies the waters. If Natexis had any credibility in their estimate, then the corollary would be that Provost presented only ~40% of the CD54 data they had in hand for 9902B despite the fact that the 9901, 02A and p-11 data appear to be relatively up-to-date.

I think the more reasonable conclusion is that Natexis severely misjudged enrollment and their estimates are not to be trusted.