News Focus
News Focus
icon url

exwannabe

07/27/25 12:44 PM

#778229 RE: meirluc #778227

It is however possible that NWBO/Advent received just enough dough to cover the treatment expenses.


What do you mean by NWBO/Advent???

We know that NWBO paid Advent $19.013M last year to manufacture -L and run Specials. That does NOT include the various 15%+ SOP contracts.

We know NWBO received $1.382M in return.

As to where the patient revenue was going, that is a huge issue. Given that NWBO was paying Advent as a service contractor one would naturally assume all revenue flowed to NWBO. Anything else would be a bit weird.

Either way, we know Advent is doing well on Specials, And NWBO is taking a heavy loss.
icon url

Slave1

07/27/25 7:04 PM

#778330 RE: meirluc #778227

Meirluc, It is accurate that more than 600 patients have received DCVax-L under the UK’s “Specials” framework, but under MHRA law, this program does not permit commercial profit. It is a strictly regulated, cost recovery pathway for unlicensed medicines. Companies may recoup the direct costs of manufacturing, testing, and delivery, but cannot include profit, marketing, or margin. As such, there would be no substantial revenue to report in Northwest Biotherapeutics’ SEC filings, even if treatments were ongoing. This is why NWBO’s financial statements continue to reflect net operating losses, and why there is no line item showing significant gain from Specials access. The absence of revenue is not evidence that the treatments didn’t occur. It is evidence that they were conducted within legal limits designed for patient access, not financial return.


Any payments made under this program likely went to Advent BioServices, which holds the MHRA manufacturing license (MIA), QP release authority, and serves as the Control Site. These payments would have covered batch specific production costs: monocyte isolation, dendritic cell maturation, lysate pulsing, sterility testing, cryopreservation, and fill finish. Because the Specials pathway is non commercial by definition, it is common and fully compliant for funds to be routed through Advent or directly reimbursed via the treating physician or institutional payer (e.g., NHS or private clinic). In that light, it is entirely plausible that the treatment of 600 or more patients was funded at breakeven, without generating material net income for NWBO itself, but rather supporting infrastructure validation, regulatory oversight, and quality assurance.


As for the scale, 600 patients over several years is feasible under the cost recovery model, especially with manufacturing centralized at Advent. These were not all treated simultaneously, and the infrastructure was already operational, having been inspected and cleared by the MHRA. The Specials program provided a means to test logistics, build regulatory confidence, and develop real world experience ahead of full market authorization. Given that NWBO continued to raise funds through equity and structured financings like SEPA, there is no reason to assume that large upfront capital was needed to “bankroll” treatment. The model was designed to operate sustainably, not profitably, reflecting the public health ethos of the UK’s unlicensed medicines pathway.


Regarding diagnosis types, NWBO has not disclosed how many of those patients had GBM versus other cancers, but under current UK law, any solid tumor type may qualify for Specials use if a licensed physician provides clinical justification and no alternative licensed therapy is available. Furthermore, SI 2025 No. 87 explicitly expands this pathway for named patient ATMPs like DCVax-L. It is therefore reasonable and increasingly likely that a proportion of those 600 patients had non GBM cancers such as pancreatic, ovarian, prostate, or pediatric tumors. While that data is not public, the regulatory structure clearly allows it, and Advent’s infrastructure is already configured to support such multi indication deployment.
Bullish
Bullish