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eagle8

09/15/21 6:44 AM

#402147 RE: Lykiri #402126


Thank you Lykiri, as always.

But pssst, don't tell EX what you heard.

GLTU

ATLnsider

09/15/21 9:40 AM

#402200 RE: Lykiri #402126

Thanks for sharing that Lykiri. I know that some people don’t trust the FDA, and some believe that the FDA new drug approvals are influenced or controlled by politics and/or Big Pharma.

But, in the case of finding a safe and more efficacious treatment that will significantly extend overall survival (OS) for most GBM patients, and in some cases be an effective cure (OS of 5 or more years) for some GBM patients, I believe that the FDA wants to be the global leader in finding better treatment options for all GBM patients, and improving the current SOC which only added about 2.5 months of OS, and has been in place since 2005.

I believe the FDA will only be guided or influenced by the DCVax-L science and data. The natural history of GBM has been studied for decades, and it is well known by all KOLs and clinicians worldwide, who treat ndGBM patients, that the current OS is about 14 to 16 months. If a treatment like DCVax-L comes along and doubles the OS to 28 to 32 months, then I believe FDA approval is a slam dunk.