Tuesday, April 29, 2014 1:54:49 PM
hps, yes you are missing something; actually 2 somethings:
1. The IMUC trial is over. The endpoint number of events was hit. They are continuing to follow the patients as they expect the PFS advantage to grow over time, and that eventually a stat sig OS advantage will be seen, and this will guide a better trial design for their Phase III (they had chosen OS as their primary endpoint for Phase II and did not achieve it); IMO they will likely choose a Phase III trial design very much like what NW has done.
2. The Phase I DCVax-Direct trial is unblinded. This means that regardless of how you interpret the embargo rules, they no longer apply as of 11:46am CST on June 1 (their poster session is 8am - 11:45am that day. So at that time at the latest, NW will be able to tell the world all about -Direct results. I would expect a PR no later than that time on June 1 to get the word out beyond conference attendees. LP has said they are 'very encouraged' by what they have seen, so I would expect the data are quite positive.
1. The IMUC trial is over. The endpoint number of events was hit. They are continuing to follow the patients as they expect the PFS advantage to grow over time, and that eventually a stat sig OS advantage will be seen, and this will guide a better trial design for their Phase III (they had chosen OS as their primary endpoint for Phase II and did not achieve it); IMO they will likely choose a Phase III trial design very much like what NW has done.
2. The Phase I DCVax-Direct trial is unblinded. This means that regardless of how you interpret the embargo rules, they no longer apply as of 11:46am CST on June 1 (their poster session is 8am - 11:45am that day. So at that time at the latest, NW will be able to tell the world all about -Direct results. I would expect a PR no later than that time on June 1 to get the word out beyond conference attendees. LP has said they are 'very encouraged' by what they have seen, so I would expect the data are quite positive.
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