NorthWest Biotherapeutics Inc (NWBO)

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Some primary reasons DCVax-l might be approved somewhat early are:

1. Recent commercial manufacturing certification for facility, and

Advent HTA license renewal was confirmed granted on December 20, 2023 after September 8, 2023 inspection and Advent corrections. (Note: Prior grant was in October 2021 after an August 2021 inspection).

2. Orphan designation for indication.

3. Months of mock inspection preparation.

4. A well plead complaint edited by two companies.

5. Started working with NICE long ago.

6. MHRA and NICE are in the midst of dramatically shortening review time averages. IRP program frees up national approval resources.

7. NICE gives proportionate review time dependent on safety of therapy.

8. MHRA review is smoother for drugs with low toxicity. (Near zero toxicity for DCVax-l)