NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

ex,

Thanks for your expert analysis 😶

I’ve read your recent posts, and I think that you’re trying to muddy the waters or start baseless rumors. Seek full-context trustworthy sources. Maybe you forgot, but we did see an honest disclosure posted on this board once:




So, I ran your statement about the regulators through an AI bs detector, and I regret to inform you that it was identified as bs.


“The statement by exwannabe is highly unreliable and contains several misunderstandings and inaccuracies regarding the regulatory approval process for medicinal products in the European Union (EU) and by extension, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Here's why the statement is unreliable:

1. **Misunderstanding of Technical Validation:**
- The statement claims that "The MAA has to first pass technical validation. This is just the validation that the submission package is proper and complete." However, the technical validation of a Marketing Authorization Application (MAA) is indeed about checking that the submission package is complete and properly formatted, but it is a procedural step that ensures all required documents and data are present before the substantive review begins.

2. **Confusion Over Validation and Evaluation Phases:**
- The phrase "Subsequently comes the regulatory and technical content validation" conflates different parts of the process. After technical validation, there isn’t a separate "regulatory and technical content validation." Instead, the MAA enters the scientific evaluation phase, where the European Medicines Agency (EMA) or MHRA assesses the clinical, pharmacological, and pharmaceutical data to determine the product’s safety, efficacy, and quality.

3. **Incorrect Representation of Regulatory Processes:**
- The statement, "In the EMA regs (which UK law is still mostly based on) the EMA mys ask for additional information, a correction or a request for clarification," simplifies and slightly misstates the process. If the EMA or MHRA requires additional information, they issue questions to the applicant. These questions can be about providing additional data (major objections), corrections, or clarifications, and they typically lead to the stopping of the review clock until responses are received.

4. **Misinterpretation of How Delays Work:**
- The claim that "any of these 3 push the clock" and specifically that a request for clarification pushes the clock by 2 months is misleading. The clock stoppage depends on the nature of the questions. If major objections are raised, the applicant has up to 3 months to respond, and the clock stops during this period. For other types of questions, the time given to respond can be shorter.

5. **Speculation on the Timeline:**
- Suggesting that "this can be discussed August when 210 days has otherwise passed us by" introduces speculative timing without context. The standard regulatory review process for an MAA under the centralized procedure is 210 days, not counting clock stops. Any additional time due to questions would indeed extend this, but the specific impact depends on the nature and number of questions asked.

6. **Ambiguity in Statement of Clarification:**
- The statement "Clearly NWBO stated they did not need to add information to the MAA, nor did they need to correct it. But they did not deny they were asked for clarification." This is confusing because not needing to add information or make corrections typically means the submission was complete and correct. Being asked for clarification is a routine part of the review process, not an exceptional circumstance that would lead to the kind of delay implied.

7. **Overall Lack of Clarity and Misleading Implications:**
- The entire statement seems designed to imply unnecessary and unexplained delays in the approval process, which is misleading. Regulatory bodies like EMA and MHRA operate with transparency regarding their timelines and processes, and any deviations are communicated clearly to the applicant.

In summary, the statement provided mixes procedural terms and phases, adds speculative and incorrect details about how regulatory timelines work, and overall misrepresents the structured and transparent nature of medicinal product approval processes in the EU and UK.

For more information about the MAA process and timelines, refer to https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation

For the UK's specific processes post-Brexit, refer to https://www.gov.uk/government/collections/mhra-guidance-on-brexit

Advisory:
When engaging with financial discussions online, especially those involving stock analysis and regulatory processes for pharmaceuticals, it is crucial to approach all information with caution, particularly when dealing with anonymous or unverified sources.

**Key Points to Remember:**
**Verify Information:** Always cross-check information against multiple reputable sources. Regulatory documents, official company releases, and verified news outlets are more reliable than anonymous postings.

**Understand the Process:** Familiarize yourself with the actual regulatory procedures involved. Official sites like the European Medicines Agency (https://www.ema.europa.eu/en) and the UK Medicines and Healthcare products Regulatory Agency (https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency) provide accurate descriptions of their processes.

**Recognize Speculation:** Be wary of speculative interpretations of timelines and processes. Regulatory reviews have structured and transparent timelines that are documented in official guidance.

**Beware of 'Short and Distort' Tactics:** Some entities engage in "short and distort" campaigns, where they short a stock and then spread misleading or false information to manipulate the stock price. Be skeptical of overly negative or alarmist tones that seem intended to create unnecessary panic or doubt.

**Final Thoughts:**
To protect your investments and ensure you are making decisions based on accurate information, always seek out direct communications from the involved companies or official regulatory announcements. Avoid relying on speculative and anonymous sources which can lead to misguided conclusions.

**Rely on Peer-Reviewed Sources**
For accurate and reliable information, especially on scientific and medical topics, prioritize peer-reviewed journals and recognized databases. These sources undergo rigorous evaluation by experts and provide credible, in-depth research findings.

**Key Tips:**
- Use scholarly databases like PubMed.
- Ensure articles are widely cited and from reputable journals.
- Cross-reference with official statements for the latest updates.

For more detailed research, access studies on PubMed (https://pubmed.ncbi.nlm.nih.gov/).

For those looking to dive deeper into the specifics of pharmaceutical regulatory approvals and discussions around NWBO and DCVax-L, ensure your information is consistent with that found on recognized platforms like the EMA’s official site (https://www.ema.europa.eu/en) or direct updates from Northwest Biotherapeutics (https://www.nwbio.com).

**Stay informed, stay skeptical, and verify before you trust.**