I only pointed out that the notion that only one trial is necessary for a global approval is not likely. I did not argue that more "trials" are necessary, they will have some light "trials" to generate data, but it's not going to be the same Phase 1-3 process, because it will already be approved, assuming approval, and they only need real world data to justify insurance coverage, under the 21st Century Cures Act.
Nor was I arguing against this being a platform. I think for a lot of people, the complexity of drug regulation is very black and white and 1 thing or the other, and it's becoming much more both accommodating and complex. It will be easier for them to qualify it for many cancers than it would have been possible before. But, you still need to demonstrate to an insurance company and many, not all, doctors that what is good for brain cancer is also useful for pancreatic or lung cancer. and remember, they have different versions, there might be a better use for Direct versus DCVax-L. So it's not exactly as you suggest, but close enough. It will take a while but not decades, to see this treatment, assuming it gets approved, used for other cancers, whether "off-label" or approved for wider indications. In the meantime, they need to focus on getting approved and I would suspect that they have a much wider amount of data than we will see from the TLD for this trial, and that they may very well bring that to useful outcome at the FDA and other regulators.
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