Thursday, April 18, 2019 9:25:46 AM
Right, I believe Dr. Liau states the reason she was interested in getting her Business Management degree (one of many degrees she has) is so that she could navigate reimbursement. That was a head turner when she mentioned something to that effect a few years ago -- before DCVax trial anywhere near completion.
At this point, I'd simply ballpark there is enough longterm survivor data for reimbursement to the tune of LP's appraisal of DCVax-L's future cost.
In about two weeks, the blinded data accumulated will have 100% of first 300 of 331 patients' data enrolled at or beyond four years from initial surgery. Four year KM estimates are locked in stone.
About 60% of the entire 331 will be beyond five years from surgery in two weeks.
I think Senti is suggesting everything is simply now limited by the SAP independent process and ultimately the CRO's capacity -- as opposed to any further true maturation concerns. She is suggesting, I think, through the CRO map, that the CRO is sufficiently large enough to promptly complete the data lock process.
While I expect that topline timing will be independent from the conference it is ultimately presented at, I'd note SNO abstracts are due by June 10, 2019. LBAs by September 1, 2019.
If the CRO is worth their salt, they'd easily meet the former date if the SAP finalization process is completed by mid May.
Still, that's all irrelevant if NWBO actually has a separate internal timeline for data lock. Aka: Les's "crescendo." Eyeroll.
At this point, I'd simply ballpark there is enough longterm survivor data for reimbursement to the tune of LP's appraisal of DCVax-L's future cost.
In about two weeks, the blinded data accumulated will have 100% of first 300 of 331 patients' data enrolled at or beyond four years from initial surgery. Four year KM estimates are locked in stone.
About 60% of the entire 331 will be beyond five years from surgery in two weeks.
I think Senti is suggesting everything is simply now limited by the SAP independent process and ultimately the CRO's capacity -- as opposed to any further true maturation concerns. She is suggesting, I think, through the CRO map, that the CRO is sufficiently large enough to promptly complete the data lock process.
While I expect that topline timing will be independent from the conference it is ultimately presented at, I'd note SNO abstracts are due by June 10, 2019. LBAs by September 1, 2019.
If the CRO is worth their salt, they'd easily meet the former date if the SAP finalization process is completed by mid May.
Still, that's all irrelevant if NWBO actually has a separate internal timeline for data lock. Aka: Les's "crescendo." Eyeroll.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
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