I would be more inclined to agree with your confir
Post# of 154899
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Posted On: 11/18/2023 10:41:40 AM
I would be more inclined to agree with your confirmatory trial but for the statements from Cyrus that the key opinion leaders were evaluating what population of patients LL might best treat going forward given the changed drug landscape. I took that to mean that they were not looking at that HTE/MDR patient pool that we treated previously. Rather, they were looking outside that box for a different patient pool.
The FDA asking for a cleaned up risk benefit analysis definitely leans in the favor of your hypothesis. But then asking for the go forward for a completely new trial protocol indicates starting a new trial to me.
And the other thing of note is that Cyrus said they had, I can't remember exactly, but something like five trial protocols mostly complete. And that if the key opinion leaders agreed that one of those patient pools was the most fruitful, then CYDY could quickly complete one of those five trial protocols. But it obviously took substantially longer than we were led to expect. That indicates to me that they key opinion leaders thought of a patient pool that was outside of those original five.
The FDA asking for a cleaned up risk benefit analysis definitely leans in the favor of your hypothesis. But then asking for the go forward for a completely new trial protocol indicates starting a new trial to me.
And the other thing of note is that Cyrus said they had, I can't remember exactly, but something like five trial protocols mostly complete. And that if the key opinion leaders agreed that one of those patient pools was the most fruitful, then CYDY could quickly complete one of those five trial protocols. But it obviously took substantially longer than we were led to expect. That indicates to me that they key opinion leaders thought of a patient pool that was outside of those original five.
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