Davidal, Concerning the SA trial, the goal was for full data on 20 patients, but if they have even 8 or 10 completers, that should at least give some idea of POC, or HOC. I figure we now have a decent chance to be somewhere in that 8-10 range of completers. Here's a summary of what we know -
1) June 5 SHM presentation -- Approx 2 completers (a 'couple', as per Stoll's comment). 10 patients had undergone at least at least one PSG (PSG 1 and PSG 2 are baseline readings, PSG 3 is with CX-1739). Stoll indicated (offhandedly) that 'a couple' had completed all 3 PSGs.
2) Sept 10 R+R presentation -- Approx 5 or 6 completers (my guestimate). At that time over 180 patients had been enrolled, but lots of screening failures. 23 patients had undergone 'at least one PSG' (compared to 10 in June, so an additional 13 between June and Sept), with approx half (11-12) of those 23 having gotten to the 2nd PSG. Varney didn't say how many of the 11-12 had completed through PSG 3, but let's say 5 or 6.
3) Late November -- Approx 8-10 completers (a guestimate). We don't have any new figures to go by, but they did liberalize the enrollment rules in late Summer, so let's say they've gotten an additional 3 or 4 completers in the two months since September. That would bring the total to 8-10 completers by late November.
Anyway, this is just a ballpak estimate, but it would seem logical to do an interim analysis on whatever SA data they have, and then issue a press release bordering on an all out hype job if there is any sign of efficacy. Varney should try to get on the Cramer show if possible, as Immunogen's CEO did a couple weeks ago. Desperate times require desperate measures, and SA efficacy is the type of thing that could catch the general public's imagination. Nothing to lose at this point, go for it.
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