Replies to post #142703 on Biotech Values

[iwfal]

CLDX -

First looking at the TN-HG group: There was a single response here, and because of the small numbers (one more response doubles the response rate) and the presumed heterogeneity of this group (after all it is a diagnosis of exclusion) together with the tremendous unmet need, it would be a mistake to abandon this group.

1)ORR - Clarification: I assume you are pointing out that among the patients that were either TN or HG or both there was only one response in the IC arm? Agreed. But I think we can probably both agree that it is to be expected that the TN group would have virtually no response - and ITT minus TN response rate is about 20% for IC. I.e. the 20% I calculated for the IC arm of the HG wo TN group is about what you would expect.

2) PFS - The PFS data, which is much more nuanced, say the same thing. The efficacy isn't there.

Here it is worth remembering that these were tremendously beat-up patients. It is quite plausible that you might see much better results in earlier stage patients with immune systems that are more functional. Obviously the regulatory bar is higher, but so is the potential.

As I noted in a response to pcrutch - I wouldn't rule this out out of hand. I'd want preclinical data on how much resistance they should expect to develop to their chemo agent in the process of becoming refractory to SOC regimens.

And, again, I'd point out that this is a company with extremely limited means.