Replies to post #169919 on NorthWest Biotherapeutics Inc (NWBO)

[Smokey21]

Optune is a medical device, and as I understand it, not subject to the same rigor as drugs and biologics when it comes to approval. At least I recall reading that somewhere. Perhaps someone else can validate if that is true.

[AVII77]

Doc logic, Flipper44, AVll7, and other veterans, I would "appreciate" your perspectives on this article, which was posted by a Yahoo forum member this morning: https://www.businesswire.com/news/home/20171117005195/en/Patients-Optune%C2%AE-90-Percent-Time-Greatest-Chance

It is a BS analysis.

Patients who comply with their therapy may tend to be healthier.

If your tumor is growing, or your suffering from the effects of treatment, and your head is sweating from the steroids and the chemo and the stress and you see you life coming to an end...... you're more likely to take off that effing cap.

The EF-14 trial was not designed to establish a causal relationship between compliance and efficacy. If they randomized people to wear it for 12 hours or 22 hours, then that would have meaning.

This is, at best, hypothesis generating.

Flipper: surprised to hear that's my view on these Optune results?

Having said that, the ITT results look good and I await results in other indications.

And yes, device approval is a walk in the park compared to drug/biologic approval.