Biotech Values

[AlohaDan]

SAPs , Dendreon DNDN "stats"

So the fact that an analysis was "prespecified" is not overly informative insofar as its suitability to be the main efficacy driver in an NDA / BLA application.


That is where you and Dew, part from me and a lot of others.9902a is hardly the main efficacy driver. And you know it so why include the above statement in a DNDN argument?

Both of you seem to be trying to imply that 9902a data will flunk on the basis of poor log p values irrespective of Cox upgrades.

Maybe you ought to reread DNDN transcripts.

9901 log rank is the primary driver for their app.

9902a is "supportive", as is th 9901+2a combo.

Inasmuch as the final approval/denial will be based on both safety and efficacy then clearly, IMHO 9902a is supportive safety wise I have heard neither of you say otherwise.

In regards to efficacy you are holding an interupted changed trial to stat standards for a BLA.

Doesn't have to be. Consideration of 9902a data will be on the basis of what FDA calls "supportive". Neither of you have addressed this definition.


At this stage I don't think anyone knows. Can you find a definition of "supportive" in FDA regs? How much will be safety versus efficacy for example.

BTW given the time frame in which 9901 was designed let's say the primary end point had been specified survival rather than TTP. Do you really think there would be any problem now?

I'm getting sick of the wasted space on this argument. I've looked at the odds and made my bet. Please at least put Dendreon DNDN "stats" in the next header post so I can skip over it.

If there is other significant info like "competitor" please so specify.