I've been giving a lot of thought to the idea that
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Posted On: 04/05/2021 7:13:54 AM
I've been giving a lot of thought to the idea that Cytodyn is considering adding trial locations in Brazil. If true, there are definitely some pros, as well as a few cons that I can think of.
First the positives. Based on recent numbers, Brazil is in terrible shape. They have an outsized number of critical patients and very high mortality. Therefore it's possible that enrollment would go quite quickly, especially if doctors start to see positive results. I would think that under those conditions Brazil could also move quickly to grant EUA and we could probably sell a ton of Leronlimab to them.
The problem with Brazil is twofold. First, their medical system is a disaster right now. That makes it less likely that CD16 patient data will be properly compiled. Imagine a scenario where 25% or more of patient data originates in Brazil and that data is unreliable. It would be a severe blow to CD16 and we could find ourselves with an underpowered trial, or one that has the types of enrollment issues that CD12 had.
The other con about Brazil also harks back to the positive I mentioned. If enrollment in CD16 is brisk and anecdotal results lead to an EUA there, then it is likely that the trial centers will stop enrollment for ethical reasons and treat patients under EUA. That would put the onus back on the US locations to fill the trial, something that I believe would take longer than most of us realize.
I think it's clear that the U.S. FDA wants nothing short of a well powered, statistically significant Phase 3 before allowing an EUA. While it is possible that Brazil can help us get there, it is also possible that it becomes a quagmire. The upside is that they desperately need a solution, and their money is as good as anyone else's.
First the positives. Based on recent numbers, Brazil is in terrible shape. They have an outsized number of critical patients and very high mortality. Therefore it's possible that enrollment would go quite quickly, especially if doctors start to see positive results. I would think that under those conditions Brazil could also move quickly to grant EUA and we could probably sell a ton of Leronlimab to them.
The problem with Brazil is twofold. First, their medical system is a disaster right now. That makes it less likely that CD16 patient data will be properly compiled. Imagine a scenario where 25% or more of patient data originates in Brazil and that data is unreliable. It would be a severe blow to CD16 and we could find ourselves with an underpowered trial, or one that has the types of enrollment issues that CD12 had.
The other con about Brazil also harks back to the positive I mentioned. If enrollment in CD16 is brisk and anecdotal results lead to an EUA there, then it is likely that the trial centers will stop enrollment for ethical reasons and treat patients under EUA. That would put the onus back on the US locations to fill the trial, something that I believe would take longer than most of us realize.
I think it's clear that the U.S. FDA wants nothing short of a well powered, statistically significant Phase 3 before allowing an EUA. While it is possible that Brazil can help us get there, it is also possible that it becomes a quagmire. The upside is that they desperately need a solution, and their money is as good as anyone else's.
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