Replies to post #109607 on Biotech Values

[DewDiligence]

EXEL—"evidence of bone scan resolution (partial or complete)" occurred in 19 out of 20 patients treated with XL184.

This is not a quantitative finding, but rather the qualitative impression of investigators based on visual inspection of the scans. There is no formal definition of “bone scan resolution” in prostate cancer.

Is that NOT good enough for approval?

Of course not, and even EXEL has not claimed that it is. Was your question serious?

[iwfal]

In prostate cancer that has metathesized "evidence of bone scan resolution (partial or complete)" occurred in 19 out of 20 patients treated with XL184. Bone/skeletal failure reductions should extend life, IMO since that is the main cause of death.

12 out of 20 had reduced pain.

Is that NOT good enough for approval?

FWIW that wasn't from the RDT part of the trial. So that really qualifies as a single arm trial - and the FDA has approved based upon single arm trials in the past when the historical data is convincing that the results seen were much better than historical. So on that basis... maybe - but all such approvals I have seen to date have been for 3rd line chemo. Not for some particular metric.

Thus I wouldn't place high odds that the FDA would approve based upon a single arm trial in this patient population.

BTW - for similar reasons (FDA very conservative) I wouldn't expect approval based upon any RDT.