Replies to post #645206 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

Gary,

The definition of phase doesn't matter. What it matters is the efficacy. If 100% percent of the phase 1 rGBM patients have positive responses and all their biomarker analyses deliver amazing data, I don't see why it cannot be approved given the fact that the safety profile of the combination is perfect and GBM is one of the rarest cancer. Would you agree there are about 400 GBM patients who already received DCvax-L + poly-iclc treatment? The real world data will provide substantial evidence for RA to grant the approval.

One thing we have to keep in mind is that all these trials at UCLA are funded by NCI. If NCI would like to see the approval, I don't see why FDA would not grant the approval.

[Horseb4CarT]

Gary,

I believe you are correct.

The phase 3 trial followed the trial design and the locked data processed according to the SAP.

The submissions must be applied to and approved based on the trial protocol and treatment administration, otherwise you would not have a consistent analysis to base approval on.

Additional trials and data may follow asap, including combination testing and compassionate care results but first approvals must be based on the phase 3 trial.