Replies to post #5645 on Dendreon Corp fka DNDNQ

[p3analyze]

>>The argument would have gone over to trial numbers then, but your statement regarding what would have been a comparison to the standard of care, IMO, would have made a strong impression.<<

Maybe, but in the end it doesn't matter, because the oncology doctors have made up their mind that provenge is a fluke. They would have gone on with the campaign after the AC without giving DNDN, or the AC members who voted yes any chance of rebuttal anyway.

Large pharms are well aware of this known fact - power the study sufficiently to measure as small a treatment effect as allowed by FDA. It doesn't matter whether the effect is clinically meaningful, their marketing and sales group will take care of the rest. Just give oncologists ample profit margin, and promote a subgroup that's been dredged up that can show a reasonable benefit. Voila, you got a blockbuster.

Avastin in breast cancer probably falls under this category. The drug at over four hundred deaths showed a hazard ratio of 0.88, which means had they stopped the trial upon observing 98 deaths, they would have shown a p-value of 0.55! Ironically, the argument for approval now boils down to that had they done a trial of 3000 subjects, then they would have achieved a statistically voodo-magical number of 0.05. Even 9902a could have achieved that with much less patients.

[DownTheStretch]

Regarding approval/failure of the interim look, I'd like to as one thing of the statisticians on the board. Could you please end each of your messages with your opinion of approval in % terms.
Example: Based on the above I believe there is a 50% chance, only a 40% chance, etc. After reading everyone's opinion, and endless arguments, I try to do this, but i's difficult. DEW....I believe you think it will fail, P3 Analyze, Oncyan, I don't know.
Maybe someone could compile all the opinions.
Here's a guy over at the Investor Village board named "japanjimmyd" who seems to work in the Biotech area, and his is his latest article.
http://www.investorvillage.com/smbd.asp?mb=971&mn=192961&pt=msg&mid=4544513
He gives it a 50-70% chance of interim approval, and talks the potential of a partnership. I'm not giving any opinion on a partnership, so I didn't want that to cloud my request for more definite opinions from all of you regarding chances of interim success. Thanks to all.

[ocyanblue]

wrt stopping at 98 deaths in the TAX 327 docetaxel trial yielding a calculated p value of 0.20, IMO, that statement would have stopped Hussein and Scher cold at the Advisory Committee meeting,

This type of retrospective statement about a different trial is good for an exploratory discussion but it would unlikely to go over well in a regulatory setting.

the failed February preapproval manufacturing inspection would ultimately have produced the same result.

If by "same result" you mean a delay of approval, perhaps. But, IMHO, it is deceptive to equate a delay of approval due to CMC matters to one due to a requirement for efficacy data. The former is fixable - heck even DSCO manufacturing issues seem to be getting resolved, while the latter could be for good. Put it another way, if CMC was the issue, DNDN would do well, but as it is, if IMPACT fails, DNDN will likely cease to exist.