I'm thinkin we may all still be sitting here in July
waiting for the results.... why? Because the Phase I results were all based on just 3 vaccinations given in the first few weeks after randomization. You had unanimouse first year survival backed up by 75% of the patients showing progression free status at 12 months. The second year, however had progression free stats begin to drop off (it had been over 11 months since the injections) Those who's therapy didn't completely wipe out the remaining cancer cells or reach some state of detente with their tumor had by then begun to relapse.
This time the treatment is significantly increased.. There are 4 injections in the first month followed by another a month later, then another 2 months later, then another and another. If I am counting correctly, there are 8 vaccinations spaced over the course of the first year and then boosters every 6 months thereafter. This may defer or moot a relapse. The phase 1 did not have this and I think this should show up in phase II stats both in terms of progression free survival followed by overall survival.
Because of this, I'm expecting to see more in the range of 90% plus overall survival at 12 months but, more importantly, north of 75% OS at 24 months. If you throw in the higher 18.8 month control group, we could be here a while.
Even at the 18.8 + 9 OS I see a good chance that this runs into next year... I do believe that we may see some dilution before we get the final results though, although in the long run if things go the way that we expect - it will not matter.
I just dont see us finding out the results this year. . If the 64 events do happen in the 4Q it will still take a few weeks to gather the results and we will still be looking at 1Q. Im really not worried about the offering at all. If this goes awhile yet before interim than I think they will wait for an offering until after the results are announced. I think it would be welcomed and may actually may cause the pps to shoot up such as what happened with ACAD.