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iwasadiver

03/05/22 9:39 AM

#448751 RE: exwannabe #448744

The issues here are not necessarily what’s going to happen in the UK since they left the EU and EMA. We have no way of knowing if the MHRA is working on specific guidelines for scale up of biological manufacturing for commercial use. It would not be a surprise to me to find MHRA is already in development of some changes that would allow a more streamlined regulatory pathway for DCVax commercial manufacturing with the FlaskWorks system. This issue has generally been a huge hurdle in the development of autologous treatments and I believe the British are ahead of the game on this. And this is why I continue to believe the UK will be the first to approve and drive the narrative for NWBO and DCVax. And I believe some of the delay we’re experiencing has to do with this and I also believe the article we’ve been waiting for will be in a European Journal. I firmly believe the UK is pulling NWBO more than the other way around