NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Jerry, I’m not so sure that what I wrote was consistent with your post. You seemed to suggest that readers should read two sentences, out of context, again and again, to conclude that the FDA is not likely to approve the DCVax therapy. I suggested that readers should read the entire interview to conclude that Dr. Liau was not actually saying that at all.

And no, I don’t think “the FDA should ignore all its procedures, ignore bad trial design, and approve dcvax regardless.” I’m not sure how you jumped to that conclusion, as I simply clarified what I believed Dr. Liau was saying.

I think the FDA should follow its procedures, and its own guidelines issued over the past couple of years clearly demonstrate that it’s becoming more flexible and taking a more patient-centered approach, so I think they will consider DCVax’s extremely benign safety profile, and evaluate the totality of evidence (including the real world evidence from the compassionate use, information arm, and EAP patients, as well as any biomarker analysis) gathered from this incredibly lengthy and data-rich trial, before reaching a decision.