NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Edit: My () were supposed to be after the next comma. Corrected below.

What I am certain of is that LP did not state they received a provisional letter from the CHM when she spoke at the December 29 ASM. What I am certain of is that Linda stated they were still involved with the MHRA cycles of RFIs. What I am certain of is she did not say they were instead now involved with the CHM process. What I am certain of is that she went out of her way to say she could not predict when marketing authorization would occur.

What I think is highly likely is that there was a CHM meeting that advised regarding DCVax-L’s maa on November 28.

What I think is more likely than not all the way up to highly likely, is that the MHRA shared minor issues with NWBO by around December 5, and that next cycle would likely take us to first week of May, but hopefully be resolved much sooner, (as guideline 2.5 wants a quicker response in such a situation) and obviously hopefully not lead to another cycle of RFI minor issues.

2.5 Final assessment phase after second RFI

There are no fixed submission dates for your responses to the second RFI. You must submit your complete response to the second RFI within 3 months, but we encourage you to submit your responses as soon as possible. If you do not submit a complete response within 3 months, we will notify you that we propose to refuse your application. In exceptional cases, we may agree to extend the clock-stop period beyond 3 months.

We will restart the clock within 3 calendar days of receiving your complete response to the second RFI as an eCTD sequence as described in section 2.4. We will assess your response to the second RFI. If all outstanding issues are resolved, we will conduct final compliance checks and grant your application by Day 210. When a positive decision can be made significantly earlier than Day 210, we will aim to notify you as soon as possible.

https://www.gov.uk/guidance/national-assessment-procedure-for-medicines