Sunday, June 19, 2022 7:11:09 PM
You are forgetting different sets of two very important words not being discussed much yet. Dead tumor, complete response and cure rate. Will FDA get on the band wagon this time with Direct or will MHRA approve before the Specials program and PIM funding gets overwhelmed? It only takes 8 weeks max for immune response with just one tumor injected. What will regulators be waiting for when memory T-cells and B-cells can tell the story with the blood work? Inject multiple tumors with Direct B+ and correct administration and watch what happens. Years? Nope. Design the right trial with expected responders and the tumors will be gone long before that with surgery to remove necrotic tissue or by immune response removing them. Trials will be stopped early with ongoing follow up to garner cure rate info. You can run parallel trials with a wider patient group that might run longer which will expand the potential patient population and wait out that info while building out for known responder population. Such is the potential of Direct and the new pathways based on known data and improvements made to D and it’s manufacturing. Best wishes.
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