Friday, August 26, 2022 11:11:47 AM
hoffman6383,
I would say that to date there is NO clearer signal that the methodology used in creating ECAs for the Phase 3 L trial will be used as an example in the upcoming published ECA guidance that will be written in stone AFTER the approval of DCVax-L by FDA based on them. THAT is the only time when the SAP is FORMALLY APPROVED, not just ACCEPTED, no matter how many signals are given that it is acceptable and will be approved. The fact that the market is waiting for formal validation instead of jumping all over this just goes to demonstrate the investment restrictions in place and that current investors have all the shares they can afford within their investment strategy and risk tolerance. Best wishes.
I would say that to date there is NO clearer signal that the methodology used in creating ECAs for the Phase 3 L trial will be used as an example in the upcoming published ECA guidance that will be written in stone AFTER the approval of DCVax-L by FDA based on them. THAT is the only time when the SAP is FORMALLY APPROVED, not just ACCEPTED, no matter how many signals are given that it is acceptable and will be approved. The fact that the market is waiting for formal validation instead of jumping all over this just goes to demonstrate the investment restrictions in place and that current investors have all the shares they can afford within their investment strategy and risk tolerance. Best wishes.
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