Replies to post #777919 on NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

We believe the MHRA is following the 150-day process that they have, but we don’t, we do not have confirmation of that. We don't have a way to be sure of that, to know it for sure, but we believe that. It, the “150 days,” quote, unquote, involves approximately 3 stages, and the time frame of each stage is approximate. So it's not, you know, on the button. 

The first stage is approximately 80 days of initial review of the application. The second stage is approximately 60-day clock stop, when the agency is going to deliver a list of questions to us, as they do in all these processes. It's not just us. They'll deliver a list of questions. They'll ask for supplementary information, all of that. And, and we will try to respond as fast as we can, which is part of why we're trying to guess what they might might ask, and try to already kind of prepare. 

The 3rd stage, which will come after the 60-day clock stop, or however long the clock stop turns out to be, to provide all the answers and info, additional information. The third stage is approximately 70 days of further review, and reaching a decision. Again, the the timelines are approximate. As as far as we've seen, there is not an equivalent thing in the UK that's similar to a PDUFA date in the US. You know, under the legislation in the US, you know, FDA can have a target date for giving you a decision. 

We don't have a target date. It'll be what it'll be, okay? 

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