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Re: KRISGO post# 773180

Saturday, 06/28/2025 7:59:35 PM

Saturday, June 28, 2025 7:59:35 PM

Post# of 822883
The problem here is that you often refer to reasonable, facts-supported projections as pumping. For example, concluding that NHS/MHRA's

1. Decentralized POC manufacturing framework that seems tailor-made for NWBO’s DCVax-L as there’s currently no other therapy in the UK pipeline even remotely aligned with it as is DCVax-L.
2. Evolving regulatory framework has effectively shifted toward the very trial design pioneered by NWBO in its DCVax-L Phase III study.
3. High-Cost Drugs list with IFR access of DCVax-L for GBM and potentially other cancers is rare and would not be granted if a rejection were imminent or already issued.
4. Lack of back-log now processing 100% of national license applications within statutory timelines. A rejection would have been communicated by now by MHRA and/or NWBO. MHRA's full attention is now on NWBO.
5. Approved DCVax-L GMP and HTA MFG licensing.

all equate to imminent approval. No guarantee here but, given the above (and there's a lot more supporting facts to add), DCVax-L's imminent approval is a legitimate conclusion to draw. The conclusion that DCVax-L's MAA has been rejected, based on current facts from the MHRA, is completely bogus!

"Against stupidity, we are defenseless"-- Dietrich Bonhoeffer, an anti-Nazi German Theologian, executed in the final days of the Nazi regime.

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