Linda is saying that no one wants to release their patient level data and the FDA guidance says that is the ideal way to move forward. There was no way for NWBO to get patient level data to compare with their own. Pretty simple really.
Yet, Medicenna has no problem running a P3 in rGBM that uses patient level data for their ECA.
Medidata AI has 9 million+ patients and their data in their ECA database. They didn’t have a problem. Liau should stick with brain surgery and not poorly designing then changing clinical trials after the data sucks.
Linda is saying that no one wants to release their patient level data and the FDA guidance says that is the ideal way to move forward. There was no way for NWBO to get patient level data to compare with their own
But Medicenna is using individual patient level data for their P3. in glioblastomaa. So the argument NWBO can;t get it is dubious.
Maybe they just preferred the summary level data? Why might that be?