I certainly hope you're right Hank, my experience is that trials move slowly especially if annual costs are being held down. If a partner came in with billions, and the trials were run at hundreds of sites, perhaps 5 years or less is possible, especially if the goal of treatment duration of 3 years or less was possible. I really don't know how low you can take the treatment duration and satisfy the regulators, 5 years for GBM certainly made the point as it's one of the deadliest, it would be likewise true for the likes of pancreatic, but others nearly as deadly kill slower, so I really don't know how quickly such a trial could be done. With hundreds of trials sites it may be possible to recruit hundreds of patients in one to two years time, if they want 5 years survival to examine, you can see where I'm going.
It's my believe that off label treatment can proceed approval by many years. With peeks at the trial authorized at a few occasions, sufficient information may be out in 3 to 5 years to get a great deal of off label treatment authorized by insurance years in advance of actual approvals. We've all learned that even after the trial ends it takes substantial time to create the documentation to file for approval. No doubt greater funding can expedite this, but without dynamic work from the regulators, all these things take time. I wish the regulators could make dynamic approvals by observing what's happening in trials, but barring that it just takes lots of time to gain official approvals.
Of course we all could be wrong about how long it will take for off label use covered by insurance if the data from off label use in the compassionate use in the UK were released and made many oncologists realize that they should be using DCVax-L now with their patient with a variety of solid cancers. I don't know if such data will ever be released, and what it will show if it is, but I suspect that DCVax-L may have worked miracles in patients with certain solid cancers. Solid anecdotal data can be all that's needed for the insurance companies to authorize DCVax-L.
Gary
