NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

I have added one more question for the ASM which I sent to DI as below:

Hi,
I have one more question to add to the list I sent to you on June 25, for this ASM on June 29.
3) Have we received an RFI from the MHRA as of yet re the MAA application for DCVAX-L? If so, when did we receive it and will you need the full 60 days to respond?

Best regards,
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From: ................................
Sent: June 25, 2024 8:45 PM
To: 'Dave Innes'
Cc: ...............................................
Subject: Questions for the ASM Q&A on June 29, 2024

Hi,
1) This question concerns the plan that management has for the future development schedule of the EDEN system to shepherd it through the regulatory pathway to approval? In which and how many jurisdictions will this take place and when and where do you expect approvals for commercial use of EDEN.
2) Why have you delayed the submission for regulatory approval for DCVAX-L for so long after the submission to the UK for their MAA? Will these submissions to the FDA and EU for commercial approval require significant modification to the submission already made to the MHRA, and how much time might that take? Have you used the last 6 months to do this work? When do you now expect to make these submissions to the FDA and EU and by when do you expect these approvals?

Best regards
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