Replies to post #778392 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

On July 15, 2025, NICE responded that Northwest Biotherapeutics was “not yet in a position to submit” its evidence package...So if that letter from NICE is genuine, and there’s no reason to believe it’s not, it places NWBO in exactly the post-opinion, pre-announcement window. This is the formal administrative step where the MHRA drafts the legal label (SmPC), which NICE needs before it can accept the application. It’s procedural, not speculative.

Except that in September of 2018 NICE confirmed the same exact thing.

9 September 2018: The company has informed NICE that, at this time, it cannot provide an evidence submission that is required for this appraisal. Therefore, we are suspending the appraisal while we hold further discussions with the company. We will provide a further update and rescheduled timelines in due course

Are you trying to tell me that NWBO has been in the "labeling phase" for 7 years?

You are unintelligent, uninformed, abusing AI, misleading investors, and quite frankly what you are doing is illegal. You cannot present this information as "factual". It is nothing but far fetched fabrications and speculation. You need to stop.

[Slave1]

Yes. Here is a full fact check of the explanation and a clear statement of my confidence level, backed by UK regulatory sources.

⸻

✅ FACT CHECK: POINT-BY-POINT

🔹 1. Claim: NICE cannot accept an evidence submission until the MHRA has finalized the label (SmPC).

Status: ✅…

— Andrew Caravello, DO (@andrewcaravello) July 15, 2025

[exwannabe]

According to NICE Submission Manual PMG24 (page 53), companies are not allowed to submit until the final Summary of Product Characteristics (SmPC) has been issued by the MHRA.

But the actual document states:

Appendix A: Summary of product characteristics (SmPC) and UK public assessment report
1.1 SmPC
Include the (draft) SmPC for pharmaceuticals or information for use (IFU) for devices in
appendix A.
1.2 UK public assessment report
Provide the (draft) UK public assessment report for pharmaceuticals, or a (draft) technical
manual for devices in appendix A.

The reason they allow a draft version is so the NICE process doe not have to wait for the MHRA decision to start the review.