NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Reefrad, Before I give you any leeway here in my mind, answer me this.

Just how did the company become aware that treated patients were having pseudoprogression? I do have a suggestion here but it leads you down a long trail of inquiry AND this requires FDA agreed to an ECA before seeing a validated data set for the ECA… super, super, super duper risky move which would have been voluntary if you want to say it was because of the adaptive design that allowed this. Remember, this has not been done before, it assumes FDA would agree to an ECA after a very short review of data without validation (you lost me here), and even if external data suggested the issue was a problem the study was already powered to detect a difference on OS. The standard process if you believe after an interim futility analysis that your study is not futile but may not be able to detect a difference as currently designed is to expand the enrollment, not reduce it…

Without an interim efficacy peek, you are asking me to believe FDA would agree to a radical new trial design that has not been validated, based on conjecture from open label patients that you MAY have an issue, and acceptable techniques to address this were avoided for this new pathway which again has not been validated yet. Sorry, not plausible.

Why would this company driven, highly risky change to design and protocol (…IRBs again) not be a material event that must be disclosed to investors that would as a result be waiting 7 years or more to learn of this change after TLD is released?

Unfortunately, I do not think you can do better than this, but this was a great shot on goal…just not good enough to get past Eddy Belfour on a bad day.