Yes hyperopia, because of the new SAP and revised endpoint buy-in from all 4 regulatory authorities (RAs), Project Orbis makes the most sense. All the RA’s are already on the same page regarding DCVax-L, and the FDA has always been the lead RA in the DCVax-L trial, they are in the best position to lead this effort.
Because of Brexit, Project Orbis did not become effective in the UK until January 1, 2021. I believe that played a part in the delay in NWBio releasing DCVax-L TLD last year. I believe NWBio & the FDA wanted to make sure that the MHRA was included in the DCVax-L TLD review process.
Don’t get me wrong, I know that the UK (MHRA) is anxious for DCVAX-L approval, and Dr. Ashkan Keyoumars is a very big advocate & he was also the lead Principal Investigator (PI) in the EU, and Advent Bioservices is quickly building-out & ramping up for GMP licensing & commercial production.
But, Dr. Linda Liau (helped invent DCVax-L & was the PI for the entire trial), Dr. Prins & Dr. Cloughsey are also anxious to get DCVax-L approved in the US. Also, Cognate is already GMP licensed by the FDA, and already has production capacity to meet commercial demand for DCVax-L in the US & Canada.
Also, as I mentioned earlier, Bethesda Maryland (NWBio) is a lot closer to Washington DC (FDA) than it is to London England (MHRA). In fact, Bethesda is only about 7 miles from the FDA, compared to London being 3,674 miles away from the FDA.
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