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manibiotech

03/25/25 7:59 AM

#756270 RE: The Danish Dude #756257

So can your Grok give FDA approval ?So why don't you ask Grok that why didn't NWBO apply BLA to FDA ? I can ask a question to grok if patient matched external controls are better than non patient matched ? I wonder what will Grok say ? 
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Legend431

03/25/25 9:53 AM

#756300 RE: The Danish Dude #756257

If the mhra has no issue with external controls why isn't this approved yet?? Should be a "slam dunk"
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GoodGuyBill

03/25/25 1:30 PM

#756374 RE: The Danish Dude #756257

That is new to me:

Thanks DD, I wasn't aware of this:

4. Platform targets tumor vasculature (tumor-agnostic)

✅ Confirmed
Source: NCT04093323, NWBO 10-K, Kalinski publications
This platform combines a chemokine-modulating regimen (CKM) with a personalized dendritic cell vaccine to remodel the tumor microenvironment by normalizing abnormal tumor blood vessels. This enables better immune cell infiltration and improves T-cell access to tumors.

Because abnormal vasculature is a hallmark of many solid tumors, this approach is considered tumor-agnostic. The lead Phase 2 trial (NCT04093323) began in checkpoint-refractory melanoma and has been approved to expand into lung, breast, and bladder cancers.

This design supports NWBO’s strategic shift from a single-product GBM focus to a broader, multi-indication oncology platform.

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exwannabe

09/18/25 12:15 PM

#788834 RE: The Danish Dude #756257

If the Roswell-led trials (e.g., NCT04093323) succeed clinically, NWBO will gain:


LMAO.

So NWBO in-licensed a trial that has now completed with an enrollment of 1.

NCT04093323

I wonder how long the analysis will take?