I agree with you, however, I have no idea how much NWBO will need to provide for either right to try or compassionate use in order to be paid for it. Things are changing at the FDA, but in the past most drug companies have balked at the idea of providing all the proprietary information the FDA insisted on to charge for the product. Either drug makers provided their products for free, or they didn't provide it at all.
As far as I'm concerned, these programs are failures as almost no products participate. If it were up to me, by the time a product reached the point where approval could come out of a trial, which in some cases can be Phase 2, a price would be agreed upon where patients can get the experimental product. The trial would move forward and all patients who received the product outside the trial would also report their outcomes. In many cases it would probably be found that non-trial patients were doing better because their Drs. aren't limited to staying on trial protocols. In our case, Drs. could be adding Poly-ICLC and/or Keytruda, or perhaps other therapies they believed would be of benefit.
I would hope that all new trials do include other therapeutics believe to work with our vaccine, and if in the experts opinion certain SOC therapies could be left out and improve the treatment in doing so, that would be done. I have no idea if Dr. Liau would suggest dropping any or all of the other therapeutics involved in the SOC if Poly-ICLC and/or Keytruda is added, but it would be interesting to see what she'd do for patients outside of trials where a specific protocol need not be maintained.
I believe that what would be a fair price for experimental treatments under right to try or compassionate use ought to be negotiated with no proprietary information required, but it should be a discount to what would be the list price post approval. All products in trials which can result in approvals should make their products available at the established price. As I understand it, when a Phase 2 trial is run with Pivotal Quality material it has the potential of being registrational. The trials can also be expanded into a Phase 3 and the patients initially in the Phase 2 are included, so the total number in the Phase 3 portion can be diminished by the patients in the Phase 2 being added. The big rub may be whether insurance pays for the experimental treatment, I believe the least they should pay ought to be the SOC costs, if something is eliminated from the SOC, at least the cost of that therapeutic should go toward the experimental therapy. Insurance has frequently been sued to pay for experimental treatment and that, or settling on payment, ought to be possible if necessary. The key is the outcome of the treatment, if the experimental treatment works, insurance should pay.
Gary
Bullish
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