NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

I actually think that's exactly what he meant. But maybe you can clarify what you mean by the market not ignoring long tail survival in NW's small Ph I Direct trial (assuming that happens)? And FDA? How would either "not ignore" it? Also if you could give an example illustrating your point that would be great, because I've yet to see FDA do anything at all (they're just not a proactive body) and have yet to see the market react strongly to OS data that blows away historical norms with no control group. I can point to lots of amazing Ph I data that doubled or tripled historical median OS rates in a small Ph I open label trial without an active comparator that did very little for the respective company's market cap. IMUC comes to mind immediately. The market just doesn't care much without an active control group. At most it's "interesting." Now if you repeat that in hundreds of patients (like with DCVax L analogues) across various disinterested academic studies then in this guy's opinion that's different, but even then the market waits...

For Direct, the market already gets it. They are already expecting "encouraging survival." They know Allan is still alive and had at least his primary tumor resected. But they also know some % less than half have already progressed and won't live long thereafter either. You just need ORR for early data to be given value by the market (KITE, JUNO, etc.) or you need an active comparator (CLDX's data in rGBM not long ago).

Now the question is, are they expecting whole group Direct data to be revealed soon? Yes, I think they are. And are they expecting some ORR with it? Imo, yes again. I think that's what helped get the pps over $8. And I think they're expectation is misplaced. So I made a contrarian move and hedged with puts. Because the market loves to overreact (either way). At least initially..

I also don't think EAMS will do much, nor a joint CI trial, and I no longer think Hospital Exemption will either. Little pops maybe. So then I see NWBO as a big mover only deep into 2016, unless L is halted early. That's why I've been suggestng investors hold until Ph III L data and Ph II Direct data are out. Though obviously this pps surge over the last month requires a dynamic response. At least from my perspective.