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sukus

02/12/26 10:16 AM

#814319 RE: sukus #814314

On Feb 24, the topic for NICE meeting will be available. If NWBO id shows up, that could be a sign that NICE will discuss about DCvax-L approval. Pray that the id will show up. That maybe what we are looking for. MHRA and NICE following the aligned pathways. The approvals come at the same time. Previously MHRA approves and then NICE approves. There can be one month or more time lapse. The new Aligned pathways seem to remove that. 
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sukus

02/12/26 10:39 AM

#814326 RE: sukus #814314

Have you heard about Type 2 variations regulations introduced in January folks? Have you also heard about Conditional MA?
Folks, NWBO doesn't need another phase 3 that can consume at least 5 years if NWBO wanted to treat Ovarian, Pancreatic and TNBC patients.
The new regulations paved the way accelerated approvals if the results at 90 days already showed amazing ORR and tumor melting and 10x t-cells infiltration into the tumors. UK for the sake of the patients with highly unmet needs to approve with Conditional Approvals. This tremendously can cut down time to pursue other indications.