Replies to post #43785 on Biotech Values

[gofishmarko]

>> Of course that would ignore dozens of trials where GMCSF did nothing for cancer patients. <<

I'm not saying the DNDN procedure is not working , just that I haven't seen much that convinces me that it's acting in a prostate-specific way as opposed to as a general immune stimulant. If DNDN or others have shown that GM-CFS fused to a non-tumor-specific protein , used in the same ex-vivo stimulation process , doesn't work as well as PAP-GM-CSF against prostate cancer , fine. Cite those studies.

I may not have made myself clear in my point about frozen Provenge. With Provenge , we're talking about a treatment where the MOA is immunological , but beyond that it's poorly characterized. Now you're going to freeze/store/rethaw/infuse a cellular infusion product and assume that no unknown ( read : confounding ) immunogenic species will be generated in that process that will cause it to be different from fresh Provenge. Not a problem if the surrogate marker is the final endpoint , but IMO a bad idea if post crossover endpoints like survival are critical.

[iwfal]

Of course that would ignore dozens of trials where GMCSF did nothing for cancer patients.

It is, of course, true that negative studies are less likely to be published than positive studies. But I've looked for negative randomized GMCSF studies in slow moving cancers. There are some. But not as many as positive studies.

BTW - obviously this is more a philosophical debate than one important to Dendreon since it doesn't really matter HOW Provenge works. As long as it does.

PS - Just because I am subscriber doesn't mean you need to use kid gloves -g-.

Clark