NorthWest Biotherapeutics Inc (NWBO)

[newman2021]

Can you show an example that anyone got an RFI after 150 days since filing the application?? LP being the CEO is saying that they are ready to respond in case. What would you say if you are the CEO? She was quite optimistic about securing the approval. She said the 150 day clock started right after Jan 24th. Seemed she does not want to comment on why it is taking longer but said they are quietly waiting for the day. You are fuding RFI so that you can fearmonger approval comes after a minimum 60 days since the date of the RFI.. No, there is no precedence of RFI came in after 150 days of filing.
We all know MHRA is short of staff and resources. Plus we are going for 2 indications. After the ASM, there is no uncertainties; artisan method, two indications. Sawston has been inspected multiple times for the artisan method which secured us the Global Manufacturing Permit; so, there is no more inspection for the approval we are seeking, imo. There is nothing more MHRA wants to complete the review and make the decision. Just the time it takes. That's all. Do NOT fud anymore. No long is scared.