Replies to post #774499 on NorthWest Biotherapeutics Inc (NWBO)

[barnstormer]

Slave, your post notes that "DCVax is not being held up because of volume. It is being evaluated based on how its therapy is made, because in autologous immunotherapy, the preparation is the product. That evaluation takes time, and it takes precision." While true, I thought how the therapy is made was known and detailed in the MAA, resulting in the formulation of the recent SI which would seem confirm that.

[jesster64]

"DCVax is not being held up because of volume. It is being evaluated based on how its therapy is made, because in autologous immunotherapy, the preparation is the product. That evaluation takes time, and it takes precision."

Slave1
Is flaskworks being used to make the batches for the compassionate care patients? If so, isn't that at least 5 years worth of proof it is reliable? Or could the hold up be because another system is being used? I recall a bio stock about 4 years ago was rejected by FDA because the sample the company provided for authorization was not produced by the same company/method that would be used in manufacturing. They basically outsourced the manufacturing to get their product approved quicker.
I'm just asking for opinions. Not creating FUD. Hoping for good news this week.

[Chiugray]

Slave1, This is just a beautiful description to illustrate the way patents work. Great post.

Imagine trying to patent a violin by claiming the shape alone has healing value. That would never hold up. But if you develop a precise method for selecting the wood, carving the body, and tuning the structure to produce a distinct resonance, that method can be patented because the process is the instrument. That is the distinction.

That is how DCVax was patented. Not as a static substance, but as a defined method: taking a patient’s monocytes, maturing them into dendritic cells, loading them with tumor antigens, and preparing them for therapeutic use. The patent protection was granted because the method itself delivers the therapeutic effect. That method is the therapy.

[Investor082]

Full of BS. From a regulatory approvals perspective, it’s always quality control that matters! Not volume, but continue to BS. Manual production (Sawston facility) was certified for commercial production recently so there is no hold up on that, but again continue to deflect & lie, just like many of LP’s minions here. LP herself confirmed at the last ASM that they don’t need Flaskworks for regulatory approvals in any jurisdiction. Manual production approval will suffice and rightly so.

Dozens of complex cell and gene therapy products approved by FDA and other regulatory bodies in the last decade. NWBO is not the first. None of them were rejected because of volume considerations. KITE is a prime example.

Flaskworks commercial production approval is so far out. It’s not even funny. No excuses when Flaskworks is not approved for commercial manufacturing in 2025 and 2026, OK?

I expect LP to come up with more excuses in another 6-9 months around Flaskworks. Maybe she will come up with supply chain or budgetary constraint issues next, LOL! Given NWBO’s pace, I’d be surprised if they actually get it approved for commercial production in 2027 as well.

What all of this posturing from minions suggests is that UK approval is far out.