by now, you'd think they would
have an in vitro assay and scatter plots
of predicted versus observed survival
for all possible classes of patients so
they know how best to flatter their product
( select the right patients). Obviously, if they
aren't sick ( incorrect diagnosis is sometimes
a big source of effect dilution ) then you probably
won't see much benefit within 3 years. If they are too
sick, presumably ( and I emphasize we don't have any data)
they won't generate an effective response in time.
By digging up dirt for the last few years and attacking problems they would now be getting flattering results rather than having to just guess. Real explanations for things
that dilute the clinical results remove doubt that the sucesses, rather than failures, wwere the flukes and
earlier ignorance now lets them use the product more
effectively ( if only has to be safe and effective when used as directed by DNDN...).
btw, someone on IV claims Gold was blaming human nature, not
the questionable data for their failure to get approval? Is this for real?
While CEO's don't often criticize their own products, you would think that finding a few problems would be expected when developing a semi-empirical immunotherapy. What have they found out about provenge lately? If Gold really thinks
this is a problem with human nature at the FDA I don't see
them investing a lot in science of even understanding the problem ( at least not the way I perceive it).
It might be entertaining to get Gold on an FDA improvement
panel and see what he suggests to fix the problem or just
ask him on a CC.
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