Replies to post #3883 on NorthWest Biotherapeutics Inc (NWBO)

[longusa]

Here is the FDA rules on accelerated approval programs:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

From my read, I think a good case could be made for DCVax-Direct to qualify for accelerated approval after the Phase I/II trial, assuming it shows efficacy. A confirmatory post-approval Phase III would be required, but that's a small price to pay to get the early approval.