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Re: Galzus Research post# 770278

Wednesday, 06/04/2025 9:58:30 AM

Wednesday, June 04, 2025 9:58:30 AM

Post# of 828453

, it is not accurate to say that the ECA was based on real-world data or included any.



For DCVax-L, the External Control Arm (ECA) was constructed using Real-World Evidence (RWE) from prior clinical trial datasets — not electronic health records or insurance claims, but structured data from published randomized controlled trials:
EF-14 Trial (NovoCure – Optune device)
CENTRIC Trial (testing cilengitide)
ACT IV Trial (rindopepimut/EGFRvIII vaccine)
CheckMate-498 / CheckMate-548 (nivolumab vs. SOC in GBM)
Radiotherapy + TMZ studies (Stupp protocol era)

Also for you to claim the MHRA is lying here "On May 22, 2025, the UK’s MHRA launched a public consultation on the acceptability of external control arms (ECAs) based on real-world data (RWD) — the exact design used in NWBO’s DCVax-L submission for GBM."
is hilarious and pathetic.

Therefore, your statement is such absolute nonsense that I won't even address the rest of your BS. You are on ignore
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