NorthWest Biotherapeutics Inc (NWBO)

[antihama]

My first reaction to your question on whether Direct has/will obtain a SPA for phase II is that the process takes a long time to negotiate but well worth it in getting FDA buy-in; hence part of the reason for the long delay in getting this study started. My second reaction is initially thinking that that this is not happening since if I was a biotech CEO, I would mention that I was negotiating w the FDA on a SPA. But then thinking about it, I usually hear about a SPA negotiation occurring at a healthcare conference or quarterly meeting CC since it’s not worth a PR till there is actual agreement. While there isn’t an opportunity to mention it at a quarterly meeting, they did have the Annual in December and I don’t think it was mentioned there. So to sum up (my reactions), it makes total sense that they are proceeding w a SPA and if I believe they are then I’m pretty peeved that they didn’t mention that they are negotiating w the FDA on it since it keep investors excited on anticipation of a SPA.

OK, I just read your follow-up where you state

Normally a SPA can only be given for Phase III trials

That could explain the hesitancy in mentioning any SPA negotiation. Never mind.