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biosectinvestor

05/17/24 4:04 AM

#692205 RE: Single Stock #692204

I agree with this. This was my conclusion as well. Initially it seemed otherwise but ultimately that was my conclusion. And as we know, 150 days can ultimately include clock off periods when the MHRA chooses to request information. We don’t have information that that happened, so we’ll just have to see if NWBO flies right through. That is possible as well. I have no doubt that they had a very thorough application given their licensing for manufacturing and all of the incredible data they had worked so hard on both for the application for approval and for the domestic manufacturing licensing process. It was likely so incredibly involved as to practically be the same as any commercial licensing process they’d otherwise go through for commercial marketing approvals. I can’t imagine that it would be anything less.
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hankmanhub

05/17/24 9:20 AM

#692229 RE: Single Stock #692204

Option 1 (receipt of MAA) doesn't guarantee a valid application. The MHRA needs to first assess the application for completeness and compliance.


Not necessarily. Once validation is done, the 150 day clock could start running from the time ORIGINALLY sent. Another way of saying the same thing is that the clock starts running from the time originally sent, subject to later validation.