Replies to post #805827 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Lykiri, thank you for sharing the CHM minutes and for pointing to the relevant guidance.

Taken together with the MHRA CHM Referral Process guidance you cited, and noting that the DCVax-L MAA review began on April 1, 2024, this clearly falls under the pre-April 2025 procedure. Under that framework, a CHM letter is issued only following a provisional negative opinion.

The absence of any CHM letter, representations period, hearing, or follow-up correspondence in the minutes you provided therefore indicates that no negative CHM opinion was issued.

Appreciate you surfacing the minutes and grounding the discussion in the correct procedural context.

[ATLnsider]

Thank you Lykiri‼️

So it seem that the “28-day letter” is only applicable if there were major objections or deficiencies. Then, the Sponsor / Applicant would have 28 days to respond or address these deficiencies.

So, it seems that NWBio is only waiting for the “Decision / Grant Letter”, which could come any day now.

Do you agree with that?