News Focus
News Focus
Followers 29
Posts 6523
Boards Moderated 0
Alias Born 04/20/2010

Re: exwannabe post# 706078

Monday, 07/15/2024 9:45:08 AM

Monday, July 15, 2024 9:45:08 AM

Post# of 822368
Transcript for those who find Youtube too difficult. This does not sound like someone expecting approval based on any submission. She is hoping for "regulatory interest" in ECAs, not approval IF they can get the patient level data from the other trials:

Patients treated with DC VX in the study were compared with the control arms of contemporaneous matched external controls who receive standard of care alone. To mitigate some of the limitations using external controls we did use a novel methodology uh to neurooncology called a make analysis is which stands for matching adjusted indirect comparison analysis which matched patient characteristics between the trials as best we could at the population level.

However we were unable to obtain individual patient level data from the previously published comparative trials so we're not able to do individual patient matching which we are all aware is a current limitation with the use of external controls so I'm actually hoping that our publication uh and the discussions around it will spur the sponsors of these clinical trials to publicly release their individual patient data so that we as a field can further innovate and get regulatory interest in the use of external control arms in neurology and oncology trials

Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
Recent NWBO News