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CytoDyn Inc CYDY
(Total Views: 805)
Posted On: 05/04/2025 10:53:10 AM
Post# of 155783
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Posted By: Riztheinvestor
Does anything think accelerated approval is a pipe dream or within reach? Been digging into it.

Examples:
• Sotorasib (Lumakras): Data for sotorasib, targeting KRAS G12C mutations in non-small cell lung cancer, were presented at ESMO. Subsequently, the FDA granted Accelerated Approval on May 28, 2021. 
• Pembrolizumab (Keytruda): Clinical trial data supporting pembrolizumab’s Accelerated Approval for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors were presented at ESMO. The FDA granted Accelerated Approval in May 2017.

ESMO presentations often come right before or around Accelerated Approval timing.















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Daniel Rizzo
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565


Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program

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Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com



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