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There is going to be no BO. LP wants NWBO to be the next Amgen and NWBO will be far beyond Amgen in a speed no one can dream about.
All Amgen's cancer drugs under development fall into the category of precision medicine as shown in the following figure. Each drug shoots for one specific target and is developed for certain type indications.
What can we know from the figure? We know that DCVax-L in combination with poly-iclc can cover all the indications that Amgen is shooting for. The data is over 15 years ago. Can you imagine what NWBO can do today by including keytruda and other components that can take care of tumor associated immuno-suppression?
No BO. You can count on it.
Didn’t Dr De Groot have a MAJOR conflict of interest that he did not disclose?
Adam a useless liar. A good CFO would ignore the idiot.
Scottie, who owns more shares Gary Friedman or LP? LP hands down.
JT,
1. We’re not minions, we’re “disciples.” That’s the one thing that LC is right about—We are disciples of science and the novel DCVax-L cell-based platform technology ✅️
2. We already know “what’s going on” because we’re paying attention. The moment that there is new information available, it will be published and we will pay attention to that too.
3. If you want to know “what’s going on” AND what’s coming in the near future, this is the main thing to remember about the new era of medical science that is dawning: ⭐️ Combo is King! ⭐️
https://www.fda.gov/drugs/our-perspective/50-years-progress-treating-patients-cancer
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175075976
Bright Boy, Agree. FYI only, I asked the AI Claude about the MIA status changing from "Investigational" to "Human".
The MIA (Manufacturing and Import Authorisation) status for "Human" use is indeed a requirement for MHRA marketing authorization, and it is typically one of the final steps in the regulatory process. However, we should be cautious about interpreting this as a guarantee that marketing authorization approval (MAA) is imminent.
Indeed, while the change in MIA status to "Human" doesn't guarantee imminent approval, it's entirely possible that approval could be imminent or coming soon. Here's why:
Final Stages: This change often occurs in the very late stages of the approval process. Some companies might only pursue this change when they have strong indications that approval is likely.
Parallel Processing: The MHRA may process different aspects of the application in parallel. It's possible that by the time the MIA status changes, most other evaluations are already complete or nearing completion.
Company Confidence: For a company to invest in changing their MIA status, they often have a degree of confidence in the likelihood of approval. This could be based on ongoing communications with regulators.
Preparedness for Launch: Companies typically aim to have everything in place for a quick launch if approval is granted. The MIA change could be part of this final preparation.
Regulatory Efficiency: In some cases, regulators might coordinate the timing of various approvals to streamline the process, potentially leading to marketing authorization shortly after the MIA change.
Positive Signals: While not a guarantee, this change is undoubtedly a positive signal in the regulatory process and could indicate that other aspects of the review are progressing well.
BB, I think you’re right. ✅️
AI commentary regarding the 10 Sep 2024 authorization, UK MIA 54923:
https://cms.mhra.gov.uk/print/pdf/node/549946
“The updates on the MIA 54923 document, particularly the shift from the term “investigational” to “human” and the references to "batch certification," could indeed be significant in relation to the pending Marketing Authorisation Application (MAA) for DCVax-L submitted in December 2023. Here’s why:
### 1. **Shift from "Investigational" to "Human"**
- The change from "investigational" to "human" implies a move from manufacturing products exclusively for clinical trials (investigational use) to producing products intended for human therapeutic use, potentially on a commercial scale.
- If the MAA for DCVax-L is approved, the product would no longer be "investigational" but would be used in humans as a licensed treatment. The ability to manufacture for human use would be crucial in ensuring that DCVax-L can be produced and supplied to patients once MAA approval is granted.
- This update suggests that the company is preparing for the potential commercialization of DCVax-L, which aligns with the ongoing MAA process.
### 2. **Batch Certification**
- Batch certification is a mandatory step for any commercialized medicinal product. Every batch of the product must meet stringent quality and safety standards before it can be released for human use.
- The reference to batch certification in the updated MIA document is highly relevant because it indicates that the necessary regulatory framework is in place for DCVax-L to be produced and certified at a commercial level, pending MAA approval.
- Once the MAA is approved, the company would need to certify each batch before it can be sold or distributed to patients. This preparation further indicates that the manufacturing processes are being aligned with potential commercialization.
### Conclusion:
The updates in the MIA document are indeed significant to the pending MAA for DCVax-L. They suggest that the manufacturing infrastructure and regulatory approvals are being put in place to support the commercial production of DCVax-L, should the MAA be approved. This preparation points to a positive outlook, as the company is aligning its processes with the potential commercial launch of the therapy. However, the final approval will still depend on the regulatory review of the clinical data and the overall application.”
AI
