The larger question (to me), though, is the bearing of PhIII enrollment on the investment thesis on NW.
For me, the development of DCVax-Direct in a much more rapid fashion, and with a dramatically changed market and regulatory environment, has put DCVax-L into 2nd place in terms of pps driver for the next 12-18 months, and perhaps longer.
The key points for me:
- DCVax-Direct appears to be having very good efficacy from the patient case studies
- Keytruda and Opdivo (both PD-1 CI's), were given AA with 21 and 24 responding PhI patients as the basis of approval.
- Immunotherapy overall is now regarded by the medical community and commentators as 'the next major leap forward' vs 'crackpot fringe' back in 2007 when DNDN tried to get approval.
- The DCVax-Direct PhI has a high likelihood (IMO) of delivering >= 21 responding patients (with vastly milder AE profiles than the 2 AA'd CIs), so NW may be able to go for AA from PhI; remember that DCVax-Direct is initially targeted to the patients with inoperable tumors, i.e., no other treatment alternatives, thereby increasing the AA chances (again IMO). The new mentions of possible combo trials with perhaps those same AA'd CIs would enhance the possibility IMO.
- If the PhI data did not get AA, then the PhII's with a more efficacious and rapid treatment regimen would likely get there. Those same factors would also deliver results much more quickly than the PhI, with a possible BLA filing and AA in 2016.
We should get a major insight into DCVax-Direct possibilities at ASCO, as the data release there will be quite mature for many of the 40 patients (given the AF-manufactured MDA brouhaha last year, I would not expect data beyond case studies until then).
News of the DCVax-L pricing and coverage mechanics (and consequent revenue ramp start) from the German HE will be a nice kicker between now and then.
