Let's think logically about when data can be presented for DIRECT. FINAL data, as was written by someone, shouldn't exist until at least July/August 2016.
Clinical trial site:
Secondary outcome: Number of patients with tumor response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Other outcomes: Number of patients surviving [ Time Frame: 24 months ] [ Designated as safety issue: No ]
•Number of patients surviving without tumor progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
I don't expect to see a waterfall chart on OS like we saw in the 51 patient data until half of the patients have deceased or 24 months from the last patient treated. If they were to present OS data now, how would we interpret it? Since there is no SOC in this trial, the 24 months is the only guideline indicating what a positive OS might be. Could someone on the board tell me what a successful OS might be? What would the expected OS be in a placebo arm? Since I don't know that answer, I am not sure if there is meaning to survival rates on patients at 10 - 12 months, and OS is what I am most interested in.
As far as tumor response goes, I do not know how they will define this. If it is the recist criteria, then they will likely present any remarkable data (large % with CR or PR) as soon as they have it - or at 18 months from the last patient treated. If they could report 50% PR+CR to this point, I think they would. Unless they see something very positive, it could take until 2016 to see a complete data set, and who knows what it might show. Of course, I am hoping they have something great to present asap.
On a sadder note, that was a painful presentation to watch. I feel bad for Les, as he did not seem prepared. I would think he could describe what the L vaccine is more effectively than he did today. Gotta Go...
NWBO 4yrs LONG now.
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