AI
Thursday, July 25, 2024 11:20:44 AM
How could MAA be rejected? This is no such possibility.
Do you have common sense? By now over one thousand of patients all over the world must have received the DCVax-L treatment paying out of their own pockets through compassionate use program. Each case has to be reviewed individually by MHRA. How is it possible that MHRA would not grant approval?
See the NCI data on biomarker measurements from 29 patients from the p3 trial. These data were measured before the DCVax-L treatment. If the data after the treatment is added, I can spot right away which mutated genes are highly overexpressed on cancer cells and can be loaded on ADCs. Nothing complicated here. It is very simple.
As for the approval, given how closely MHRA and FDA have been interacting over the past several years, it strikes me MHRA is waiting for the readiness on the US part. But this is my conjecture.
Do you have common sense? By now over one thousand of patients all over the world must have received the DCVax-L treatment paying out of their own pockets through compassionate use program. Each case has to be reviewed individually by MHRA. How is it possible that MHRA would not grant approval?
See the NCI data on biomarker measurements from 29 patients from the p3 trial. These data were measured before the DCVax-L treatment. If the data after the treatment is added, I can spot right away which mutated genes are highly overexpressed on cancer cells and can be loaded on ADCs. Nothing complicated here. It is very simple.
As for the approval, given how closely MHRA and FDA have been interacting over the past several years, it strikes me MHRA is waiting for the readiness on the US part. But this is my conjecture.
