Replies to post #428191 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

FeMike,

Folks are looking past your properly conservative approach because it’s too toned down for the reality which is that manufacturing, needed regulatory changes, revised SAP buy in and patent protection has been holding NWBO hostage since 2015 when regulators kept 17 SOC/placebo patients out of this trial because of ethical concerns by identifying SOC/placebo only before crossover as unethical when the patients had an outside chance to get the treatment on a compassionate use basis. Fraunhofer claimed enrollment was only done to the point statistically necessary and enrollment from Germany was never disclosed so as to protect the blind and the public from having reason to form a lynch mob to speed up “the process”. So yes you are “technically” correct but the exuberant are also correct in assuming “ the process” is nothing more than a very burdensome necessity created to protect the status quo which your “technically correct” comments represent. You are meeting a rather significant disdain on this board for defending the process thinking of the status quo is all. Since 2015 the cost to investors has been time opportunity loss but buying in the teens kind of made up for that big time for some of us. Today is a day to celebrate without pulling back so hard on the reigns. Best wishes.

[dennisdave]

The certification is not ONLY to produce DCVAX products but to produce Human Investigational Medicinal Products Under which DCVax falls, correct.

What I dont understand is some asserting that Advent would not be enough to get FDA approval but only EMA/Uk. The production facilty will be good enough for the FDA under certain circumstances.

[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.