Replies to post #58758 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

PD1 inhibitor.....that is.

[doingmybest]

If it is true that 13 cancers will be studied, and, if the trial has a PD1 arm I think FDA will need to and will want to be intricately involved and there will an SPA. This will be potentially a scientific breakthrough of enormous proportions and the last thing the agency would want is to have it get stuck in a gray zone for an extended length of time due to a lack of clarity of any data, of any endpoints, or, of anything. I do think there will be a PD1 arm, it has become too obviously necessary. Just thinking of what this could mean to medical science for cancer patients is enough to shake anyone. I was hoping Q1 would have cleared the air with DCVax-L, but, now I am hopeful Q2 will clear all the air here including L, Direct, investigation and future financing, though I think the first two will dwarf the next two in impact.

[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.

[Doc logic]

flipper44,

SPA? Yes, I believe they know enough about MO to do this and if endpoints are chosen correctly be done with conditional approval in months perhaps instead of years. We saw the potential of a fast acting immune response in mice and although this should take longer in humans, the results should still be relatively quick.