dennisdave,
Sorry to have to disagree but for 7.5 years we have been waiting out manufacturing sufficient to meet expected demand, regulator guidance changes, and maturing data that provides clear long term separation between what is seen in historical or even contemporary control data and this trial’s data. Your answer would be fine for some smaller scale operation like DNDN had but this is not what is being prepared for. We all need to think big.
The current wait is simply because there are not enough qualified techs to meet the massive ensuing demand created by SOC designation for GBM, rGBM as well as off label use and clinical trial combos worldwide for multiple cancer types. This kind of demand is what happens when multiple jurisdictions are involved in a clinical trial with a platform treatment tech that proves itself to be a breakthrough treatment not only for GBM and rGBM but very likely for all solid tumor cancers.
Linda Powers, Dr. Linda Liau and Dr. Keyoumars Ashkan all want this to get to as many patients as possible as quickly as possible but the supply chains must be checked, double checked, backed up by other qualified suppliers etc before manufacturing approval can be granted and they must prove that they too are ready to meet the expected demand.
With personalized medicine and multiple key component sources needed on an international basis it’s like Linda said, if you need it in 2 years it must be being worked on today and all the regulators know this too. We are looking at a transformational massive scale up effort for a personalized medicine that requires extremely accurate accounting of all materials, processes and procedures.
As I have stated for about 2 years now, manufacturing, manufacturing, manufacturing. The big picture absolutely requires it for all parties involved. Think big because like Linda said, “Go big or go home”. Back in the day we used the term paradigm shift. Best wishes.
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