Druggie clearly suggested it in earlier posts, and I do believe others have suggested it. I don't know that the submission couldn't justify a tumor agnostic finding while asking for GBM approval. I certainly don't know what's in the submission, I really don't believe any of us do, but it's clear that the company's not being shy about calling the DCVax's tumor agnostic.
I believe that if additional trials are needed for a tumor agnostic label it won't be done with DCVax-L alone. I think that other combinations including Poly-ICLC and/or Keytruda will be included in the trials, and these trials may be sponsored by more than one company. If this is the case, the trials could involve many trial sites with the intent of being fully enrolled in a matter of months and initially evaluated after just one or two years after being fully enrolled. The complete trials might be run in under 5 years.
If more anecdotal evidence of efficacy in other cancers build, I believe that off label acceptance of DCVax-L will become acceptable to many insurance companies and the approval may not be that impactful as DCVax-L has already become part of the SOC.
Gary
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