A lot of prominent posters on this message board are not familiar with the procedural rules the MAA follows while it processes an MAA. For your convenience, I am attaching a link to the MHRA guidance on these procedural rules here:
The CHM conducted its first review of DCVax-L on June 27-28, 2024 and issued an RFI to NWBO regarding the DCVax-L MAA. Please review Section 2.3 of the aforementioned guidance in the link.
The November 27-28, 2025 CHM meeting was the second review of DCVax-L by the CHM. Pursuant to Section 2.4, the CHM had three options regarding DCVax-L after that meeting. "The assessment of your response to the first RFI will be completed by Day 150 (60 calendar days after the procedure restart date) and we will notify you as follows:
1. if your response has addressed all our questions, we will notify you as soon as possible that your application is undergoing final compliance checks; 2. if we identify minor outstanding issues, we will send you a second RFI letter by Day 150 (see section 2.5); 3. if there are outstanding major objections which if unresolved would preclude a marketing authorisation or orphan designation, you will receive a CHM letter by Day 150 (see section 2.6).
We will stop the clock when we send out a second RFI or CHM letter."
We are 181 days past the November 27-28, 2025 CHM Meeting. It is very unlikely that the CHM recommended a straight up approval of DCVax-L because the MHRA would have announced approval months ago. Therefore, Option 1 is probably off the table. This leaves Options 2 and 3.
The MHRA will approve DCVax-L's MAA if it issued a 2nd RFI and we are in Section 2.5. The MHRA will probably reject the DCVax-L MAA if it issued a CHM Letter and we are in Section 2.6.
I recently learned that NWBO failed to promptly disclose an FDA ordered suspension of its Phase 3 Study in August 2015. NWBO was silent until after it was disclosed by a German affiliate of the European Medicines Agency and was widely commented upon on investor message boards. This has shaken my confidence in the honesty of NWBO's management. I no longer trust Linda Powers to follow US securities laws by disclosing unfavorable information about NWBO where there is any kind of an argument that she does not have to disclose.
I want to respectfully discuss the evidence of what has been going on with NWBO since November 28, 2025 and make a rational decision as to whether NWBO is responding to an RFI pursuant to Section 2.5 or it is appealing tentative CHM advice to reject the DCVax-L MAA pursuant to Section 2.6. This is the central issue for NWBO and nothing else even begins to compare in importance.
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