Dendreon Corp fka DNDNQ

[nerdseeksblonde]

they need to act serious toward cassette.

What do you think it would cost to have 2-3 full
time scientists and support stuff dedicated
to the cassette science and technology?
For that matter, what can Shiffmann do to
get some help from AFFX for serial gene expression
results from the provenge soup? Correlating
this with survival, raw and improved, would
help a lot. Not sure what the gene chips cost
but compared to waiting for clinical data
when you don't know exactly what your drug
is it could look cheap in retrospect. If you noted
increased genes for various cytokines it may
be easier than probing the broth
at random for things you expect.
With a serious science effort, the FDA may look
more favorably on a Phase IV ( not saying this
changes the efficacy data, but for related influences
it sure beats a cartoon and testimonials).


Right now, that effort could align well with regulatory
requirements. Presumably to maximize the alignment,
you would want to find an in vitro assay that
you have some hope of correlating with real
clinical outcomes ( improved survival, not raw
survival ala Urdal vs Small).

Besides a lab effort, if they want people to take the
modelling seriously, they should be trying to show
how consistent it is. There should be scatter plots
everywhere showing predicted survival and the
effects of things on observed survival.
Starting with a plot of the placebo
group with observed=predicted would help- even
if a bit noisy. If this can't explain 6 month
differences they need to keep working. It could
be very simple in terms of time of diagnosis compared
to disease course but they need to come up with
markers or "trajectories" that can measure these large
offsets.