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Wednesday, May 15, 2024 7:48:11 PM
BETHESDA, MD, USA I November 17, 2016 I Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today joined the University Medical Center (UMC) of the Johannes Gutenberg University Mainz in Germany in announcing a Phase II clinical trial program combining DCVax®-L and Pembrolizumab (Keytruda®) for colorectal cancer with liver metastases.
I have no idea what's going on with this trial and whether it ever actually happened. Maybe somebody on the board knows something. I know that several trials proposed during that time frame did not go through.
If you're looking for a way that our FDA could approve DCVax-L without us knowing they were doing it, there's an easier way: We have reciprical agreements with numerous other countries' health agencies to accept their drug approvals if the FDA want to. I've forgotten the name of the program but it was discussed quite a bit on this forum in the last year when it was put into place. I think there's about 17 countries and the European Union that signed the agreement. So, technically, UK's approval could quickly trigger approvals by other countries. For example, I would not be surprised if Canada follows UK's lead with little or no examination of NWBO's MAA within a few months of UK approval. Would the US do this? I don't think they would, but we do have a president who's son died of brain cancer and who is pushing the cancer moonshot program. I would not be surprised to hear he knows about NWBO and DCVax and I would not be surprised if he urges FDA to approve DCVax-L as quickly as possible. Obviously, he has no control over FDA decisions. Personally, I would love to see Joe Biden use an approval of DCVax-L in the US as an example of his Cancer Moonshot's success.
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