NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Iron Mike, I understand your point and the need to dig in when feeling attacked. I agree that the certification does not guarantee MHRA approval. It is, however, a required step that is necessary for DCVax to be approved.

I also believe that you may be wrong about how broad a license is. My understanding is that the steps of the process are validated and approved. The process used would entail the chemicals added in the exact amount, incubation times and temperatures, the cytokine profiles tested and acceptable range of the output. The stability requirements to prove that the product remains fully active for the duration of the storage. These are all unique to DCVax, maybe not just -L, but not likely a CAR-T product.

- Microbiological, biological and chemical/physical testing of finished medicinal products, i.e. final testing prior to Qualified Person certification for the purposes of batch release;
- Stability testing of finished marketed medicinal products;
- Environmental monitoring and or process simulation (media fill) work for sterile product manufacturer; or
- Biological testing if it is required to be conducted in accordance with the GMP Guide as described in Annex 2 of EU GMP

And

- Completed any building/refurbishment work relating to the activities to be licensed
- Completed the facility, equipment and process qualification and validation
- Draft procedures and documentation to illustrate how the site envisage the operations and PQS would work in practice in place

I am pretty sure that they don’t have to perform unnecessary inspections and they don’t need to be quick about it either.

You are minimizing this critical accomplishment for sake of being ‘right’. This is a huge sign that success is near.