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dennisdave

07/08/24 5:55 AM

#704426 RE: FeMike #704417

ooh come Mike, stop being so serious. The New York poster did say "probably off and wrong just for entertainment".
Everyone here by now heard of your warnings of the prolonged delayed timelines based on the last ASM.
I told you once and Im gone tell you again. Take a break Take a Sissi. Stop being so serious.
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dennisdave

07/09/24 5:22 AM

#704705 RE: FeMike #704417

Powers said that the reason they have submitted with the MHRa first is because the MHRA is the fastest in their review process.
Now that we found out that most likely the MHRA approval process will take until the end of the year, aka one year in total, we can conclude that is the same timeline as the EMA would have taken. From EMA website

Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting clock stops when applicants have to provide additional information.



Therefore in my view, it would have been better for NWBO to submit with the EMA first.
The EMA has no backlog
The EMA carries much more weight than the MHRA
The EU and other countries follow the EMA such as Australia. Therefore the EMA is a much bigger market than the UK
Time wise it would not have made much difference