Hodge, let me add a few thoughts on a different path to a best case scenario. Before I do, though, I would strongly suggest you call NWBO and speak to them about compassionate access right now. There is no downside and possibly life-changing upside, right?
As to best case for DCVax-D (my abbreviation), there is precedent for drugs going to approval after Phase I or II. One that is going through this possibility now is SRPT with a treatment for Duchene Muscular Dystrophy after a trial with 12 patients. This kind of early approval can be considered if there is no other treatment available. Since we are considering inoperable tumors, perhaps the case could be made for early approval after the Phase I/II results. NWBO says expected completion is June 2015. By then as well, top line results from DCVax-L Phase III should be in. So if DCVax-L Phase III meets the endpoint, this would strengthen the case for DCvax-D I would think if it is also showing efficacy.
So then in going for approval, an NDA (New Drug Approval) request form is submitted to the FDA. This contains the written up detailed trial results, including robust statistical analysis. It typically takes 6-9 months to prepare and file the NDA after trial data received. The FDA then assigns an approval not-to-be-later-than decision date (called the PDUFA date - PDUFA = Prescription Drug User Fee Act = the body of law governing the FDA) of either 6 or 10 months from the NDA filing date; the 6 month is the accelerated approval timeline.
Looking for best case from company date of June 2015 for DCVax-D data yields June 2016. Using flippers estimate of Nov 2014 data yields Nov 2015 best case approval.
Once again, though, please call the company today to see about compassionate access right now. Best wishes to you.
