Monday, December 06, 2021 11:53:54 AM
The problem with the burn rate is that they are not spending enough. I do not believe they have the internal expertise, experience or capacity to get through the BLA process on their own. Same with commercialization.
So for me, the scary part of the delay on the release of TLD is that I see no evidence they have done anything substantial to prepare for submitting a BLA. I believe that if they were doing anything substantial to advance DCVAX-L towards regulatory approval and commercialization, it would be reflected in their financials by a jump in spending. As for what they are doing if they aren't working on the BLA? Other than working on the Sawston facility, I have no earthly idea.
I certainly don't know for a fact that the burn rate is too low, but I know that spending typically ramps the closer a biotech (with no approved product) gets to approval.
Perhaps MI Dendreon can share some insight on whether the burn rate tells him something about where the company may be with respect to the BLA process and preparing for commercialization.
So for me, the scary part of the delay on the release of TLD is that I see no evidence they have done anything substantial to prepare for submitting a BLA. I believe that if they were doing anything substantial to advance DCVAX-L towards regulatory approval and commercialization, it would be reflected in their financials by a jump in spending. As for what they are doing if they aren't working on the BLA? Other than working on the Sawston facility, I have no earthly idea.
I certainly don't know for a fact that the burn rate is too low, but I know that spending typically ramps the closer a biotech (with no approved product) gets to approval.
Perhaps MI Dendreon can share some insight on whether the burn rate tells him something about where the company may be with respect to the BLA process and preparing for commercialization.
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