Wednesday, August 06, 2025 8:44:58 PM
"I think what is truly frustrating is we see the amazing results in the trial Slave1 provided and we wonder why isn't someone screaming about this from the rooftops?"
You see, the problem is that you see these results through an extremely biased lens. There is another viewpoint that does not see what you see - like, at all. In fact, it sees a trial that did not prove anything due to obvious concerns about its validity. The concerns began right from the start with patient selection. They became even more serious in 2015 when the company conducted an efficacy IA that almost certainly indicated non stat, and was followed by an enrollment hold enforced by the FDA. They decided to carry on with the trial despite the obvious trend toward failure and made the radical decision to just up and change the endpoints and the comparison groups (with no patient-level data) a couple of weeks before data lock in order to get the results they wanted (well, almost the results they wanted. It's still nothing revolutionary at all). You see, the problem is that the vast, vast majority of people (including Wall Street, Big Pharma, reputable doctors and scientists, regulatory agencies, and many more) see it this way, the correct way. Nobody wants to touch this trash with 10-foot pole. You are in a tiny, tiny minority that is shrinking by the day.
You see, the problem is that you see these results through an extremely biased lens. There is another viewpoint that does not see what you see - like, at all. In fact, it sees a trial that did not prove anything due to obvious concerns about its validity. The concerns began right from the start with patient selection. They became even more serious in 2015 when the company conducted an efficacy IA that almost certainly indicated non stat, and was followed by an enrollment hold enforced by the FDA. They decided to carry on with the trial despite the obvious trend toward failure and made the radical decision to just up and change the endpoints and the comparison groups (with no patient-level data) a couple of weeks before data lock in order to get the results they wanted (well, almost the results they wanted. It's still nothing revolutionary at all). You see, the problem is that the vast, vast majority of people (including Wall Street, Big Pharma, reputable doctors and scientists, regulatory agencies, and many more) see it this way, the correct way. Nobody wants to touch this trash with 10-foot pole. You are in a tiny, tiny minority that is shrinking by the day.
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