I feel a lot better today after the dr been interview last night and the 2nd PR further explaining the situation. It is clear leronlimab works is a broad spectrum of patients. This is huge info, this drug is not specific to a narrow symptom or patient condition, it works. The problem is that we had too small of a trial and the wrong PE. Many here have raised the concern about the arbitrary 28 day mortality and its problems. Few here realized (including myself) that when you have a relatively small trial, the range of patient recruitment leads to in related comparisons and making it difficult to present a conclusive apples to apples assessment. If this was a 1000+ patient trial, we would not have the problem with too many over 65 on treatment and too few in placebo. We essentially have a phase 2 trial with a ton of solid data. Any way the data was sliced, leronlimab works. The fact that we might need to add 140 patients is extremely encouraging. It says the FDA gets it, they just need the trial to have a end conclusion that allows them to approve. They know the drug works. We also don’t know if this added protocol is even needed, the higher ups are looking at this and they are the ones to bend the rules. Nader is just following the rules.
If we had a larger trial that could lead to approval, we would be still enrolling today. With this data out, I think it will be easy to enroll. It will take a couple months, but we know it will work, there is no guessing.
Also, compare this situation to all other treatment options. Those trials had to be mined to get some showing of effectiveness. With CD12, no matter how you look at it the drug works, the trial design is the problem that prevents the P value. The extension is purely to fix the trial problem, not to twist the data to make a drug that does not work look like it does.
Let’s also keep in mind, the data is out, anyone from the medical community and the BP world can see this drug just proved it is not just an HIV drug. BP now has the luxury of approaching cytodyn knowing they both know what leronlimab can do. The very near term data from Nash and the cancer basket trial will really put the spotlight on this. The world does not need to understand, the industry now does.
If we had a larger trial that could lead to approval, we would be still enrolling today. With this data out, I think it will be easy to enroll. It will take a couple months, but we know it will work, there is no guessing.
Also, compare this situation to all other treatment options. Those trials had to be mined to get some showing of effectiveness. With CD12, no matter how you look at it the drug works, the trial design is the problem that prevents the P value. The extension is purely to fix the trial problem, not to twist the data to make a drug that does not work look like it does.
Let’s also keep in mind, the data is out, anyone from the medical community and the BP world can see this drug just proved it is not just an HIV drug. BP now has the luxury of approaching cytodyn knowing they both know what leronlimab can do. The very near term data from Nash and the cancer basket trial will really put the spotlight on this. The world does not need to understand, the industry now does.
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