Monday, May 25, 2026 5:19:21 PM
Ski, the company has said that manufacturing will begin in the US with compassionate care. Of course, that could change. If that's the case, the facility has to be in a state that has approved compassionate care in a form that allows the company to be reembursed well enough to make the plunge.
Not to say that DCVax-L approval by the FDA won't be fast behind compassionate care. Or even parallel. Again, with two facilities in the US, one could be for compassionate care and one for commercial manufacturing.
Let's not forget that it will likely be the compassionate care programs in both countries that help provide RWD needed for approval of other cancer types.
Remember, we have already seen that patients will pay for their own care for DCVax-L which is now the only new treatment to expand life in GBM in 20 years. And they've paid for it in other cancers, as well, at Sawston. Linda and company has noted this good response from patients several times.
Not to say that DCVax-L approval by the FDA won't be fast behind compassionate care. Or even parallel. Again, with two facilities in the US, one could be for compassionate care and one for commercial manufacturing.
Let's not forget that it will likely be the compassionate care programs in both countries that help provide RWD needed for approval of other cancer types.
Remember, we have already seen that patients will pay for their own care for DCVax-L which is now the only new treatment to expand life in GBM in 20 years. And they've paid for it in other cancers, as well, at Sawston. Linda and company has noted this good response from patients several times.
Bullish
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