NWBO now has FIVE+ asset categories & the company’s clinical pipeline has expanded. Shorts are finding their position more & more precarious with each step of progress.. that is the reason why we see the fud flood here 24/7
Fact ✅️: Regulatory agencies may choose to consider independently peer-reviewed publications as part of their overall analysis. The MAA review is just one of several regulatory reviews to come as NWBO is developing several technologies/products. The examples below are relatively recent publications & Dr. Kalinski is currently working on another paper right now …
Fact ✅: The MHRA has already awarded several approvals, including their approval of the MIA (a prerequisite of the MAA) & their ongoing support of the DCVax-L Specials Program.
Regarding the P3, enrollment completed years before 2020, but patients continued to be treated & followed under the trial protocol as trial participants after enrollment closed. The P3 trial concluded in 2020, & data lock happened in Q4 of 2020…
COMBOS with checkpoint inhibitors & other agents are much more recent & have reached P2 for both DCVax-L & the Roswell DC technology platform.
NWBO (via UCLA) has leveraged rigorously peer-reviewed grants from NIH, and Roswell has also been awarded peer-reviewed grants from the U.S. DoD (DoW) to fund clinical trials for their respective DC platforms…
Fact Check: ✅️ Patients are being treated TODAY with DCVax-L in an active PII combo trial.
✅️ Patients are being treated TODAY with the Roswell DC product in an active PII trial.
✅️ Patients are being treated TODAY under MHRA authorization of the U.K. Specials Program.
The multiple technology platforms licensed to NWBO have progressed & advanced into a new era of combos. DC combos with TLR & PD1 technologies are relatively new and combo studies have only recently reached PII. (Additionally, the commpassionate use Specials Program is ongoing today and continues to produce more and more safety & efficacy data beyond the data collected from the landmark P3 which does not include any data about PD1 or TLR agents)… Merck’s pembrolizumab is being studied in combo with multiple DC platforms licensed to NWBO and Dr. Kalinski recently cited MTA agreements with Merck.
Below is one very noteworthy example of DC vaccine in combo with TLR & PD1 blockade. We will see what comes next. There are multiple TLR agonist agents, multiple checkpoint inhibitors, and NWBO has in-licensed multiple dendritic cell platforms. Partnership(s) & collaborations announcements could include any of the companies that make TLR agonists or checkpoint inhibitors.
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