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Haven't seen the presentation but from the helpful reports, it would seem that 0518 needs to be tweaked in order to increase the chances of part B success. We got a hint of that when we had a bit more clarity re the biomarker presentation. Currently, data seem sufficiently promising but the expectations created in part A need to come down. To what extent? Difficult to say but probably significantly.
Let's assume that in part B the reported response rate (to-date) of 30%, whereby half develop resistance to therapy, results in a disease control rate (DCR) of 15% (i.e. the ones who don't develop resistance). In part A 10% was the DCR threshold in order for the trial to carry on. So 15% is close to the part A threshold (NB. That's on the assumption that "response rate" is the same or close to DCR. )
A good way to tweak the trial would be to focus henceforth more on the patients that have the biomarker as the response rate would go up. Hence, among the patients with the biomarker response rate might go up to 30% (just an example) and for the rest 15%. If that scenario materialised, that would still be an unequivocally successful result.
Focussing more on the patients with a biomarker (without dropping others), would make sense. However, the elephant in the room question remains: what % of patients have this? 5% or 50%? We still don't have the answer.
Now, "Late this year to early next year" sounds more like February / March 2022 (at best) - in a way it's a throwback to 4D's earlier days.
Re Blautix and Asthma any negotiations could last a few more months but we could be pleasantly surprised at any time.
Taking into account the above, I'd be pleasantly surprised if we saw anything more than a modest recovery in the share price.
Otherwise, looking forward to seeing CNS entering into clinical phase!
Finally, the above are just my early assessment of the situation and without having seen the results or emailed IR so could be wrong - also I'm not clear on the definition of "response rate" vs. DCR In any case, DYOR.
"Haven't seen the presentation but from the helpful reports, it would seem that 0518 needs to be tweaked in order to increase the chances of part B success. We got a hint of that when we had a bit more clarity re the biomarker presentation."
Respectfully Michael, no one on here has reported anything along those lines about the presentation and DP/AS certainly said nothing of the sort.
All AS said was that if they continue to see similar biomarker data when they analyse the data from more patients then it could be that they can use that knowledge to better hone in on those most likely to respond. None of that means part b needs to be tweaked to increase chance of success though. It just means if it transpires that they are able to better target then why wouldn't they.
They were careful not to comment on the data coming out of the 0518 trial. If they had it would have been materially significant info.
They are still recruiting until the end of the year. I wonder if they can use the latest biomarker data to guide recruitment.
There would be a medical and ethical justification if they thought they could prove a higher likelihood of efficacy in those with the right biomarkers as it is potentially life extending.
Boonco let's be fully clear : I didn't say that the tweaking was reported or that it was said by you or any other poster. It is just my HYPOTHESIS which could be right or wrong. The reason I think that is because of the delays in reporting the data and the reference to the biomarker (as per earlier post).
I also mistook the following statement from your post to be referring to part B success ratio. Having discovered that the acronym ICI refers to Immune Checkpoint Inhibitor... I realise that such assumption was incorrect.
"AS: MRx0518 + Keytruda: 30% patients respond to ICI. Of those half develop resistance to therapy. Data later this year & into next year."
Michael,
Your opening sentence was ""Haven't seen the presentation but from the helpful reports, it would seem that 0518 needs to be tweaked in order to increase the chances of part B success." which I think it is perfectly reasonable to suggest implies that your thinking in your post relied at least in part on what others reported.
Indeed, you confirm this in your reply when you admit "I also mistook the following statement from your post to be referring to part B success ratio. Having discovered that the acronym ICI refers to Immune Checkpoint Inhibitor... I realise that such assumption was incorrect."
So to summarise, both my interpretation of your original post and my response to it were perfectly reasonable.
Misunderstandings happen, it's not a big deal