Biotech Values

[Summer2762]

I had a chat with IR about this.

IR claims that Daiichi Sankyo wanted to be more conservative about the trial design as the data on the percentage of the patients in the MARQUEE trial (patients with nonsquamous histology) expected to have high MET overexpression as well is a little bit soft. That's why the co used a significance level of 0.01. The SPA is for 0.05 as usual. Even though I asked the question in many different ways as I can (and got the same answer), this answer does not satisfy me (why play with alpha rather than power or the effect size?). I dont know if I would trust the co on this one even after the chat.

Also, another question that also came up here on this bb was whether all the patients in the control arm of the second line P2 HCC trial, after the trial results were announced in January 17th, were allowed to crossover to the Tivantinib arm even though they did not have PD at that time. The answer was no.