Solved -- CRC/ICI dosing "mystery".... Min 21
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Posted On: 10/20/2025 12:32:41 AM
Solved -- CRC/ICI dosing "mystery"....
Min 21 & from MGK's transcript:
"And recently, we have collated all of our oncology data into a briefing book so that the folks at FDA can now understand what CytoDyn is trying to do. And as a result, it's opening options to us about how we can even further improve our CRC study. So I'm excited about that as well."
Dr. J said on this Rx interview, the meeting is for FDA to understand what Cytodyn wants to do.
Last week I said ...maybe they're just following the past CRC protocol for ease of moving along right now without causing confusion, because modifying it later is an east fix,,,,I guess
Well that's exactly what / why they did what they did ---that1st keep it simplified to FDA in the Briefing Book.
Then, they will say ok -- now that we're on the same understanding, can we modify CRC to include ICI asap if / when Upregulating optimum shows ??
The FDA understanding all this 1st, is why they are filing mTNBC protocol after Briefing Book meeting
My bet:
FDA says --
*DSM will be honored on CRC.
Because of our not having past CRC/ICI data.
*mTNBC protocol for indications submitted / Chemo / followed by ICI dosing....Approved.
Because of our Ladies of Leronlimab data
Min 21 & from MGK's transcript:
"And recently, we have collated all of our oncology data into a briefing book so that the folks at FDA can now understand what CytoDyn is trying to do. And as a result, it's opening options to us about how we can even further improve our CRC study. So I'm excited about that as well."
Dr. J said on this Rx interview, the meeting is for FDA to understand what Cytodyn wants to do.
Last week I said ...maybe they're just following the past CRC protocol for ease of moving along right now without causing confusion, because modifying it later is an east fix,,,,I guess
Well that's exactly what / why they did what they did ---that1st keep it simplified to FDA in the Briefing Book.
Then, they will say ok -- now that we're on the same understanding, can we modify CRC to include ICI asap if / when Upregulating optimum shows ??
The FDA understanding all this 1st, is why they are filing mTNBC protocol after Briefing Book meeting
My bet:
FDA says --
*DSM will be honored on CRC.
Because of our not having past CRC/ICI data.
*mTNBC protocol for indications submitted / Chemo / followed by ICI dosing....Approved.
Because of our Ladies of Leronlimab data
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