Not a lot of updates since $NWBO's 10K (its only been ~6 weeks), but the one thing that stood out to me the most was the apparent progress with the Marketing Application of DCVax-L.
➡️MAA
Recall, for Q4 of '24 the 10K stated, in relevant part:
“The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during and after the inspections.”
In other words, it sounds like inspections and Requests for Information (RFI) were still happening as of Q4 '24.
Fast forward to yesterday's Q1 '25 10Q and the language surrounding the possible RFI(s) and inspections is gone. Recall, the 10Q is for the following time period:
"During the first three months of 2025, the Company continued its progress on multiple fronts, including the following”
✅Thus, it appears it's MAA approval decision time.
Some other quick comments from the MD&A section of the 10Q:
➡️Manufacturing Scale up
Not much changed since the 10K other than $NWBO stated they have plans to half (or more) the expected backlogs of ordering equipment that are 10-12 months long.
➡️Manufacturing in the US
$NWBO set a timeline to have these plans finalized by this summer.
➡️DCVax-Direct Trial
INDs still projected to be filed Q2 '25. Recall, this is for an adult and pediatric trial. IND is plural in the 10K.
➡️Dr. Bosch's June NYAS presentation topic
Unless there is another presentation we missed, it appears we have Dr. Bosch's NYAS topic for his June '25 presentation:
“The Company continued its internal testing of certain immune booster agents that it has in-licensed, to identify the most useful booster agent(s) and combination(s) of agents for enhanced DCVax-Direct products. The Company currently anticipates making a presentation about this at a scientific conference in June."
➡️Timing on Roswell Clinical Trials
Sometime after summer '25. The US manufacturing agreements have to be in place before additional Roswell trials can start.
➡️Possible Roswell/Pittsburgh Clinical Trial
We have another possible clinical trial in the pipeline:
“While the clinical trials of the Roswell/Pittsburgh DC technologies are waiting for the US manufacturing agreement to be reached and implemented, the Company has identified another technology in the Roswell/Pittsburgh portfolios that could proceed with clinical testing in the meantime. This technology is designed to mobilize the “endogenous” (resident) DCs inside the patient’s body through cytokine conditioning regimens.”
➡️Compassionate Use Programs
Nothing changed here since the 10K. Ongoing for a "variety of cancers" and the program is expanding.
➡️Litigation
Entering discovery.
➡️Items that were curiously absent from the 10Q versus the previously filed 10K
🔲Commercialization plans 🔲Required pediatric trials in connection with the MAA 🔲Applications for approval in other countries 🔲Reimbursement (NICE) 🔲The IND that was supposed to be submitted for the DCVax + TLR agonist trial in Q2 '25 🔲The potential acquisition that was targeted for Q2-Q3 '25 🔲Plans to pay for everything
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