The FDA has always made companies prove dosing. Yo
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Posted On: 06/26/2025 6:35:41 AM
The FDA has always made companies prove dosing. You could easily argue that Cytodyn didn't do themselves any favors by assuming 350mg would be enough in many previous trials, or by wanting to look at both doses and ending up with small numbers of patients that gave, at times, conflicting data as to which would be better. See Nash/Mash.
In oncology specifically, the company admittedly has been trying to nail down MOA up until late, and it's not like we've had a thousand patients take the drug for cancer indications. So it's not at all surprising to me that the FDA would want to see a study that gives 350 a look but that also agrees that moving to 700 is possible. It's careful, and not at all unlike the FDA. Yeah, it sucks when we're starting to see a clear picture of what 700 can do. But that's through our eyes as investors and not through the slow and pedantic eyes of the FDA.
Additionally, the clinical trials dot gov site isn't a real time database of every last bit of information on every trial. I believe it gets updated when it gets updated. I think, for instance, it still only says there's just a single location. I see many people relying on it like it's up to the second and official when it's more of a rolling process that may not currently but eventually will/should have information that is already in play at the clinic level.
In oncology specifically, the company admittedly has been trying to nail down MOA up until late, and it's not like we've had a thousand patients take the drug for cancer indications. So it's not at all surprising to me that the FDA would want to see a study that gives 350 a look but that also agrees that moving to 700 is possible. It's careful, and not at all unlike the FDA. Yeah, it sucks when we're starting to see a clear picture of what 700 can do. But that's through our eyes as investors and not through the slow and pedantic eyes of the FDA.
Additionally, the clinical trials dot gov site isn't a real time database of every last bit of information on every trial. I believe it gets updated when it gets updated. I think, for instance, it still only says there's just a single location. I see many people relying on it like it's up to the second and official when it's more of a rolling process that may not currently but eventually will/should have information that is already in play at the clinic level.
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