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Thursday, September 09, 2021 10:29:51 AM
As to ethics, trust, and competence, ethics for someone in the legal profession are fairly straight-forward and I don't necessarily see any ethical problems with the timeline issues. As for trust and competence, I would argue that we as shareholders are a lot better off if management realizes they were mistaken or made a poor choice or didn't understand something and then changed course over a team that never learns, never acknowledges mistakes, and bullheadedly continues on a path that new evidence suggests is no longer a path to success.
Obviously, I need to make some assumptions about why things happen and why management has acted the way they have. IMO, on several occasions management has received new information in the form of trial results, blinded or unblinded, or regulatory and classification changes, which have caused them to reevaluate how they move forward. I have little doubt that they expected the trial to conclude years ago but that when they saw the data and the high survival rate, they had to change course. That is not an easy decision. Maybe they could have gotten approval by now but at what future cost? They have now gathered tremendous amounts of data that will help them and will help patients in the future that they would not have had if they ended the trial early.
Similarly, when they concluded the trial and saw the results, I believe that they had to reevaluate their planned announcement of TLD. They had planned a series of PRs around Flaskworks and Sawston, a presentation at a conference, and who knows what else. But based on the data and changes to the definition of GBM, and the advice of the SAB, they changed course.
I understand that people have trust issue, I get that people doubt management's competence. I am simply not one of those people. However, it is not simply through some blind faith but because the circumstantial evidence points to a different conclusion and I would prefer longterm approval and use as the new SOC over short-term revelation of TLD to shareholders.
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