Doc,
While I agree with you that it will happen, I suspect that it will take awhile to happen. To begin with, I would think that we must meet demands of GBM patients before capacity can be devoted to off label use. If we get authority to use the FlaskWork device this could happen rapidly, but without it I believe it could take some time. Secondly trials take time to get started, I would be happy to see new trials initiated by 2nd or 3rd quarters of next year.
I don't doubt that the demand will be great, hopefully we can meet the demand with the supply. If we get the FlaskWork device approved, I believe that the mass production of the units won't take that long, likewise St. Gobain Glassworks should be able to deliver the disposable cassettes rapidly. As a guess, I've got to believe that thousands of FlaskWork units could be manufactured in 3 to 6 months, and tens of thousands of cassettes ready in that time. With approximately 4 batches a month possible with each FlaskWork device we could be delivering tens of thousands of batches of the individualized vaccine in less than 6 months.
I believe that the word of what we're doing is spreading through the brain surgeon community. I would hope that surgeons all over the world are properly preserving the cancers from patients for some time. If I'm correct about that, I believe an assessment will be made of the patients in an attempt to prioritize delivery of vaccine to those who still can be benefitted. If I'm right about this, the demand for just GBM patients alone will be huge once approvals are achieved.
Let's hope that the FlaskWork device can rapidly be approved, if not I suspect it will be some time before the supply will come close to meeting the demand. In the mean time, if cancer surgeons all over the world become aware of what's happening with GBM patients, I believe it will behoove them to preserve tumors properly so a choice to make a vaccine in the future is possible. Many cancers are slow growing, but nonetheless deadly, a vaccine made from the tumor, with leukapheresis at the time the vaccine is to be made, might make the difference between life and death years after the surgery if the tumor is properly preserved.
In short I'm suggesting that we could have a tremendous demand for both GBM and off label use at day one of approval. Certainly the release of TLD and the Journal should get the attention of many, but I suspect that many already know and may have been preserving the tumors properly for years. Hopefully if this is the case the patients are still considered to be viable for the treatment.
Gary
