Regarding $40M to Cognate; I know I might be way off rationalizing that kind of money to automated mfg development, but I also know that the cost of such development is extremely high. You look at infrastructure expansion to assess where that money could have gone, but up-front R&D costs are not the same thing as subsequent expansion once a design has been decided on. They said in their SEC filings that they have finished the design work for automated DCVax-Direct mfg, but not for DCVax-L. The efficacy threshold for L approval is 4 months PFS, so they are probably trying to match that in terms of expected reimbursement for 4 months PFS. For that to be worth doing probably requires automated mfg for L, but they have not been able to accomplish such so far, so throwing money at it through Cognate would be their only option. I believe that 10's of $millions might make sense in that effort. Maybe.
In the end, if they only get approved for a subgroup, which many believe cannot happen, that subgroup might show much higher efficacy than 4 months PFS. If so, the reimbursement will be much higher than they are trying to prepare for, so automated mfg might not be needed. But they are shooting for all the marbles, and must have a feasible mfg plan in place prior to consideration for approval by the regulators.
I do believe that if they have been paying Cognate these large sums for R&D in automation, that they would then own that automation, ie patents, etc.. If the deal is that Cognate then owns it, then I believe the internal investigation will red flag that. Similar issues for land purchased for expansion. Or if these expenditures are ridiculously high, as I agree it appears, then I believe the investigation should report that.
