NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

You’re framing this as “taking sides,” but it’s really simple, there are some things that are not a matter of opinion.
They are regulatory facts, and they can be verified easily by anyone willing to do 10 minutes of homework, however most here refuse to do or have annd will not want to admit to what they could conclude if they put on reading glasses.

1. Facts (not interpretation, not opinion)
A. MHRA rules require that the intended commercial manufacturing process is reviewed as part of the MA.
This is a standard ATMP requirement. A CMC update must be reviewed if the intended commercial process changes.
This is not up for debate it’s basic MHRA/EMA ATMP law.

B. NWBO has stated that Flaskworks is the core intended commercial manufacturing method.
Read the Nov 20 PR: Flaskworks is “key to enabling” commercial production, and “central to large-scale production.”
For those that will now tell me I have only quoted a part (I do that because otherwise the post gets too long https://investorshub.advfn.com/boards/read_msg.aspx?message_id=177004494 Manual is used for Specials. Flaskworks is the intended commercial method.

C. If a sponsor were to pretend that manual is the intended commercial method while actually planning Flaskworks, that would be considered misleading the regulator. If the MHRA granted an MA based on “manual,” and NWBO immediately submitted Flaskworks afterward, MHRA would likely suspend the manual-based MA while reviewing Flaskworks. Any ATMP company knows this. I bet that NWBO will not want to risk that.
This is not my opinion this is how CMC oversight works.

2. My interpretation (because NWBO has not explicitly disclosed this) Based on the above facts, my interpretation is that NWBO submitted a CMC update mid-review. Why? Because:
- MHRA explicitly said the application is “not in backlog” even though the 210-day clock is far exceeded.
- NWBO’s Nov 20 PR confirmed that commercial production is moving to Flaskworks/Grade C.
- NWBO does want to maintain a healthy and working relationship with the MHRA and not mislead and swindle the MHRA as Senti and Flipper are suggesting.
Both perfectly align with a sponsor-side clock stop, which is exactly what happens during a CMC update review.
No drama needed just standard ATMP process.

3. I do not believe a CMC update adds “a year or more.” That’s an overreaction and I never said anything like it.
The Typical timeline would be 6 months extra counted after the regular 210 clock on days have passed (depending on the readiness of the facility (Grade C suite and the MHRA inspections of Flaskworks). My best estimate: end Q1 2026, assuming the validation of the first Grade C suite completes early next year.

And no, a CMC update does not have to be disclosed as material information. Multiple ATMP reviews (I can list them if needed) made mid-review CMC updates without disclosure. It’s standard practice.

Again Im dizzled by those (senti and fans) that want NWBO to fail with a losing manual production only to win a few months; that's also my opinion.
I want NWBO to succeed with Flaskworks the ONLY way it can successfully produce DCVAXL