Saturday, November 03, 2018 4:44:23 PM
I have been away for a long time and have little capacity to keep up. I agree with your assessment that the study ends when the last patient crosses three years. I believe they would need to send protocol amendments to all IRBs for approval otherwise. This is quite challenging and time consuming, so most companies just work on an extension study and start fresh.
They don’t need to have submitted an LBA in order to advantage of the medical press at SNO. They can still utilize the PR contacts from the meeting to send out a top line press release and have the booth available to address questions from the medical community. This would still allow them to avoid encore presentation challenges at the next meeting of choice. The timing is tight for this should they have chosen to wait until the very last runner crossed the line. I am think data release associated with SNO is about Fitty-fitty.
MI Dendream
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