NorthWest Biotherapeutics Inc (NWBO)

[koman]

"Maybe the regulators will say "no more changes", that's always possibility. I believe that is what was meant by their risk disclosure. Koman seems convinced that the company will not be able to continue to treat patients until the end of the study without recruiting again. I'm not sure I agree with that. If they're over 300-patients, then there's no reason why the regulators just let the study meet its final endpoint and the OS results age and the regulators to decide if the vaccine is contributing to life-extension or not. " RK

First, I also thought that there was a possibility that the company initiated the hold to make some more "enhancements" but I thought it was poor timing when they were ramping up in enrollment and would have easily finished enrollment EOY 2015 so that alone kind of argued against the company initiating the hold. To clarify your statement above about what I believe, I believe this p3 trial is OVER. It just is a matter of the company disclosing the full reasons for the hold that was initiated last summer. So there is every reason for the regulators to tell NWBO to just design another p3 trial with OS as the primary endpoint and no cross-over if there was any hint of OS difference in this current p3 trial. Don't blame the regulators for doing their job.