Replies to post #435375 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Reefrad,

I respect the experience of those on this board who have gone through the process and you are probably right that my position is too speculative but my sense of things is that this situation is unique in many ways and that both regulators and NWBO are going through some growth pains together. With this being an orphan disease indication, a novel treatment and a trial that began with old regulations and measures inappropriate for use in this type of trial but the only ones available at the time, there may be even more than normal communication. Also what is technically blinded to us and the company can be glaringly obvious to them, clinicians and regulators as well. I believe the halt was just such an instance and that since that time blinded data confirmed what was seen to cause the halt and the obvious under enrollment created. Regulator intervention was seemingly confirmed by comments from Fraunhofer that enrollment was done only to the point statistically necessary. Regulators and NWBO had their hands full trying to keep the lid on the blind then after the German site announced the halt and the enrollment was cut short creating a negative influence on powering. It was bad enough that some confoundment was created by the crossover trial design implemented to give patients a chance to receive the vaccine made from their own cells but the lowered powering created a double whammy. This is why I believe this trial has created a unique relationship between regulators, NWBO, the lead investigators and to some extent the research institutions they are tied to. For example, I am not aware of any other unapproved treatment being recommended for use in a compassionate use setting by a lead investigator of said treatment for an indication other than that for which it was being investigated in a compassionate use situation. This is a push for widespread use even before approval. I don’t know whether or not to think this is a slap in the face to the process and those governing it or just a way to try and speed it up.
Anyway, this is my rational for what has been going on. I certainly respect your point of view as it is powered by normal understanding of the process which is the most likely historically speaking. Best wishes.