@UpsideDownUnder brought information that no one in the discussion was aware of. I assume you didn’t know either because you have been asking questions and providing your hypotheses on what might have happened - just like the rest of us? Even asking people if they have other ideas? People have done just that - in the spirit of trying to understand what's gone wrong (and in some cases, following your invitation to). In any case, I don't think its wrong to examine theories presented, particularly where no evidence is provided (might not be there or cant be shared publicly). Someone even suggested that it was the management reshuffle that created this!
Are you saying that what
@UpsideDownUnder is saying is what happened? The supporting evidence you provide (the 15% drop), clearly supports the view that the head-to-head trial was not welcome. But, are you saying that that's what accounted for the 70% drop, or part of it? Or perhaps it triggered a wave that has simply continued?
Its unfortunate
@UpsideDownUnder you have decided to disengage! Yet all that was requested is confirmation or just some directions to the source, which you say is public? I don
IMO: UpsideDownUnder - you probably chose the wrong words (FDA disallowed) when making your statement. That is what created the challenge. The other points around it can be debated (or digested and acted on or ignored), but the FDA one is massive.
But, it is clear from the follow on material that you have some deeper than average knowledge of the trial(s). Not many people study trial protocols that deeply to the point of being able to argue over an aspect of them that is clearly a challenging aspect. You know what you are talking about, although I suspect you may not have referred to the full trial protocol - the only one that Clarity have shared publicly. The detail on the hierrharchial construct to the reference standard (7.4: with histology as Level 1) is the answer to that question, but I can understand why general conversations would not have that level of detail. Its the results of COBRA that have brought histology to the fore, and even with those, only 9 had biopsies done, so I can see how that would feed into the debate.
But I think what might have been missed in those discussions, is that in CLARIFY, lymph node biopsy at prostatectomy is part of standard management and not a special trial insertion, versus AMPLIFY (mothered by COBRA) - where Lymph node biopsy is not always done.
Disagreements may be over including histology in the BCR patients (COBRA-AMPLIFY trials) is understandable, but that can not be on the CLARIFY trial, which has histology already FDA approved.
Did the investment analysts miss that difference?Investment advisers don't always get things right! I have an example of a stock research report that mentions a result in a manner that understates the effect of a treatment, due to a flawed application of what is otherwise correct mathematics by the company! It happens!
I hope you remain engaged.
(20min delay)