Replies to post #42584 on Biotech Values

[jellybean]

Agreed. Shoo-in is a bit stronger than I would state as only the company and the FDA see the entire data set and you never know what nasty detail could be lurking. Given von Eschenbaum's previous statements regarding cancer drugs (he thinks there need to be more treatment options), my best guess is that the drug will receive accelerated approval.

BTW, Feuerstein's subset analysis is based on fewer than 58 patients total. He also seemed to leave out the little detail that for HRPC patients increasing pain is correlated with progression.

thanks for the reference!

[AlpineBV_Miller]

Mitoxantrone is approved as a pain palliative but has shown no survival benefit

[DewDiligence]

GPCB just took Feuerstein to task on today’s CC for botching the subset analysis re the components of the PFS endpoint in the SPARC trial.

[iwfal]

For Feuerstein to say that Satra may affect only pain and not survival is premature, IMO; I know of no MoA explanation of why this should be true. Let’s wait to see what the actual survival data show.

p.s. I have not seen the “separate analysis” that Feuerstein referred to, but I don’t think I need to.

I would submit that if the p value for death is substantially the wrong way, then the NDA is at substantial risk.

As for MOA - chemo is dangerous. It doesn't seem unreasonable to suppose that two chemo drugs together may kill patients.

Of course, having said all of that I will further state that I know nothing at all about the protocol or the drug other than that it is another platinum drug.

Clark