1] “Nothing you posted there invalidates theresults and...

1] “Nothing you posted there invalidates theresults and interpretation of such.”

This was my disclaimer statement, made to reassure people more than anything else. I am not on some mission, and I have no ulterior motives. I am just sharing (and correcting), in exchange for the learning that I get from a lot of you on this platform, including you Flotsam, Nathan, and indeed the Chartists - of which I admit the lessons are not going too well at the moment!


2]“… its been 18 months since dosing in theselect trial and pluvicto median OS is 15 months…”

(I will respond based on an assuming that the SELECT Trial plans to use Survival Analysis - as was used in the Tagawa (et al) paper that reported 43 months OS. Yes, I am a TLX holder, but Telix is doing a million things - I get lost). Anyhow, here is my comment;
In Survival Analysis (the statistical tool), OS is not a simple time-to-time comparison. The tool uses median OS, which means that even though TLX591 was dosed 18 months ago, the median OS cannot be assumed to be 18months yet. It depends on when 50% of patients have died (sadly), and that might already have happened, or (I hope) might not have happened yet, which would be good for the patients. I care less for the company.

As one can expect, in trials, some patients will outlive the median OS, while others will succumb earlier. Even in the Pluvicto studies, some lived much longer and some died earlier that the 15 months reported. Look at the results from the Tagawa paper (the one that reported 43 month OS): the range reported was 19.9 – 64.7 months. So, it is possible that TLX591’s OS might be longer than 18months, but we won't know until more survival data matures. If it is - GREAT! I am a male, and I have a vested interest in this!

Tagawa paper: https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.32072


3] On Clarity being selective by reporting the complete response, you said: “… that's exactly what management here did to get the pump goingby crowing about one complete response and neglecting to mention the twosubjects who showed no response at all in the first cohort, until 3 monthslater …”

What Clarity did is consistent with processes is scientific discovery where human experimentation is involved. These are CASE reports: a valid form of science reporting.
NEW human experimental findings often start with case reports, then case series, then cohorts of patents (observational followed by randomised blinded clinical trials).
Don’t take my word on this: The medical community received this positively: The complete response case was accepted for oral presentation (and presented) at the European Association of Nuclear Medicine (EANM) 2024 Congress. In the hierarchy of medical conference presentations, an Oral Presentation is the highest ranked form of presentation (ahead of posters).
In their conclusion, the authors say: This case shows forthe first time the anti-tumour effect of two doses of 67Cu-SAR-bisPSMA (S248, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026).



The other cases that Clarity did not mention earlier were reported the normal way, because they behaved as expected. The primary goal was safety, and clinical outcomes were secondary.

If you wish to compare: NOTE that TLX591 has a failure rate of 40% (both on PSA and Imaging). So, I don't think your criticism of the 67Cu-SAR-bisPSMA in relation to the other 2 patients holds any water: they all responded as expected, and this was from one dose. TLX591 was on 2 - 3 doses. Perhaps you missed the point that the complete responder was after repeat doses - which was only done via EAP (to my knowledge others didn't). This was a dose determining study, so cure was not part of the deal (as was the Tagawa study).


4] And if the OS results are just due to cherrypicking why was PFS better than pluvicto in ph2 and why is further PSAreduction seen up to 12 months later?

Sorry, I a not sure what you are referring to here.
a) I never said the results are due to cherry picking, and what I presented is not my opinion. I simply presented the FACTS as reported by the authors; that the 17 patients from whom the 43 months OS was derived, are a subset of a larger cohort. These 17 were the group that had the drug at the highest dose, and it is they who had the best PSA response (87.5% of any decrease, and 29% at 50%+).
b) In the entire cohort, there were also some non responders: 40% as assessed by PSA and also by Imaging.
The point I was making, by the way, was related more to my concerns around the way you are dismiss the PSA as a measure of treatment effect. Cherry picking is when you tout the 43 months survival (as Telix have done), while dismissing the role of the PSA (which is what you are doing): How can you do that when the PSA is what was used in the trial to pick the 17 that gave you the 43 months survival?