Thanks for establishing that Slave. While I don't know how far the British went in validating Advents costs in making DCVax-L in this program, by working with Advent they didn't get into what would be proprietary information from NWBO.
Here in the US a similar program exists under "Right to Try" the problem is drug developers must give the regulators what they see as proprietary information, so practically no companies allow their product to be used under right to try.
I believe that it would be far better if once preliminary trial demonstrated sufficient efficacy to run a pivotal trial if regulators and drug developers could negotiate a right to try price, without any proprietary information being revealed.
If such an arrangement did have a small profit margin, it would be a drop in the bucket when compared to the cost of development of the product.
People are wrong in thinking that most of the cost of drugs is in the cost of making them, whether it's pennies, dollars, or thousands of dollars it's a small part of the price of the product. From genesis to approval, it's typical to spend into the billions, that's a major consideration in establishing a fair price to sell the product for. The cost of the equipment that makes the drugs may run into many millions, or even billions, but once you have all the equipment, the product itself may cost pennies. Pricing products for right to try or compassionate use should take all this into consideration, as well as the benefit that may be achieved, and perhaps medications that aren't needed because of the experimental drug. After such consideration and negotiation for the price for a product in trials, Drs. who wish to use it should be able to. Either patient, insurance, or a combination from both should cover the cost of the drug. If some costs are eliminated, insurance should be responsible for at least that much of the cost regardless of the evidence that it could be effective. All patients in such a program should have results reported in what could be considered a Phase 4 trial.
I believe the problem is that agencies like the FDA create programs like the right to try and say they've solved the problem. If very few companies are willing to play by the rules they require, the problem isn't solved at all. What I'm suggesting would be negotiated at the time a Pivotal trial began, and people could pay for the drugs beginning then. The use would be up to the Dr. and their patient, so anecdotal evidence would be accrued on off label use of the product early on.
I don't believe the data from the compassionate use in the UK has ever been reported publicly, but I believe the regulators would have it if they asked for it.
Gary
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