I was very clear. That is not enough time to follow all the enrollees 5 years out. Plus the primary endpoint was PFS and they ended on an interim review. The date of the publication is not the critical point.
The trial could not possibly have run 695 patients out 5 years, fully. It needs to be projected. You should understand this. They likely did not immediately enroll all 695 as of the first or even 2nd year of the trial. That is just not how it works.
And one of the PR’s from the company is very clear, it was based on an interim review and was ended early. Those were projections. They did not run it out for all the specific 5 year survivors they had to live 5 years. That is a secondary endpoint anyway. It’s not an immune therapy and does not kill tumor cells, so you don’t have the issues with inflammation and pseudoprogression.
But it also has no mechanism for causing apoptosis of tumor cells. It’s mechanism, they claim, is that it does not affect normal cells but slows the growth of actual tumor cells, meaning it works where there is any regression only. At 21,000 a month, 5 years, if someone lives that long, is very expensive. 2 years is ridiculously expensive.
It’s not a practical treatment as it is for any healthcare system to offer routinely as it is set-up now. It seems to be highway robbery. But I can see why they are working so hard through surrogates to try to stop treatments like DCVax-L, it would mean trouble for their business model.
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