Replies to post #794752 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Jester, most of my life I've known investors who were certain that many things were material events, but companies didn't PR these things, so in their judgement, they weren't.

The fact that DCVax-L was put on the High Cost List in itself was found in a public document, I believe the company need not PR it because it's already been publicly revealed.

I frankly don't know that all correspondence with the regulator during the approval process isn't also considered private and not to be revealed. If that's the case, and if the company and regulators discussed a tumor agnostic label and the regulators said, show us your proof, while it's certainly huge if they accept it, but noting would ever be said if they took a look, but told the company, do some trials to prove it. Therefore, I don't believe the company would reveal it, and frankly think the regulators would have told them not to.

Some companies certainly are far more open than NWBO, but many of them are far more interested in bringing in new investors than they are getting approvals, they keep the money flowing by claims that their drug, developed nearly half a century ago, is the cure for something, and they believe their latest target is that disease. I'm certainly speaking of CVM, but there are others I believe as well.

Gary

[GoodGuyBill]

You can't put words in her mouth or say she meant something else.

Show me where I put words in Smyth's mouth. I quoted her directly and responded to the framing she used. You're the one interpreting what she "meant"- not me. Smyth wasn’t making a regulatory declaration; she was answering a question using the same language the questioner used: “an immunotherapy for glioblastoma.” That’s not a limitation of the therapy- it’s a reflection of the question’s scope.

You’ve already acknowledged the following statement is true:

DCVax-L is built on a patient-specific, tumor-targeted mechanism: dendritic cells are extracted from the patient’s blood and “educated” using lysate from that patient’s own tumor tissue. These trained cells are then reintroduced to stimulate a targeted immune response- not against a generic cancer type, but against the unique antigens of that individual’s tumor. That’s why DCVax-L is considered cancer agnostic. It doesn’t rely on markers unique to glioblastoma- or any specific tissue type. It targets tumor-specific antigens derived from each patient’s tumor, regardless of origin.

So why won’t you acknowledge that this mechanism directly supports the position that DCVax-L is cancer agnostic?

As for the MHRA’s scope- did you see the full MAA submission? Do you know what data beyond the Phase 3 trial was included? Furthermore, if the MHRA can’t expand beyond the applied indication, then explain how DCVax-L ended up on the High-Cost Drug list with an expanded indication. That didn’t happen by accident.