NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I give up. You guys are nuts. Here it is one more time. Good news, patients may hopefully have a new therapy in about 0 to 19 days thanks to patients, NWBO, researchers, caregivers and investors, and I can move on. 🥳

Here is the breakdown of those two types of letters according

1. The Two 28-Day Letters (Reset)


• Letter 1: The "Schedule 11" CHM Letter (The "Refusal" Letter)
• Sender: CHM Secretariat.
• Purpose: To tell the company the CHM is leaning toward "No" and invite them to an appeal.
• The Deepesh Context: This is what that email was talking about. It’s for when things have gone wrong.

• Letter 2: The "Positive Advice" MHRA Letter (The "Approvable" Letter)
• Sender: The Licensing Authority (MHRA).
• Purpose: To communicate a Positive Recommendation from the CHM, but with Conditions (SmPC changes, labeling, or site-specific requirements like Sawston).
• The Rule: Per the MHRA's own guidance on reclassifications and innovative medicines, once the CHM advises in favor, the MHRA (not CHM) sends an advice letter. The applicant has 28 days to respond to those conditions.

MHRA Compliance checks then take a number of days.