Replies to post #764691 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Everyone assumes that the NWBO MAA is backlogged.

(1) That assumption is wrong. According to the MHRA (as of 31 March 2025), not a single application is backlogged. Read this from the MHRA:

"On 31 March 2025, we cleared all backlogs related to licence applications for innovative and established medicines. All new national licence applications submitted after 1 September 2024 continue to be assessed within our target of 210 days, with an average timescale of 160 days in March."

I only noticed this information later.

2) According to the MHRA the DCVax-L application is not considered backlogged because NOT a single application is backlogged. The DCVax-L application review is off the clock and, therefore, under MHRA definitions, it is not classified as backlogged. ("Backlogged," according to the MHRA, means the MHRA is responsible for the delay not the company.)

(3) Thus, the real question is: why is the DCVax-L application off the clock?
A. They have been approved, but we haven't heard that so thats off the table for now.
B. The only plausible reason is that NWBO received another RFI (Request for Information). This is a factual deduction based on real-world information and timelines. This deduction also aligns with NWBO's own statement in their April 1, 2025 10-K filing, where they wrote:

"The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during, and after the inspections."

How much more confirmation do we need?

(4) Timeline from here on:
A. It is likely that NWBO received another RFI stemming from the on-site clinical trial inspections conducted by the MHRA between mid-September 2024 and the end of February 2025. Preparing that RFI and sending it to NWBO would have taken time, likely occurring around mid- to late-March 2025 — just before NWBO’s last 10-K was filed. Let's assume that NWBO will take about two months to answer this RFI. They would therefore submit their response just before ASCO (early June), which would also explain why NWBO canceled their ASCO presence and said they want to stay focused on the application.
B. After NWBO submits their response, the MHRA review clock will start running again.
If the MHRA then takes around 60 days for final review, that would put a possible decision around the end of July 2025.

It sucks but that is really where we are now.