Fast track and ODD only help if you have a treatment that works well in patients. Yes it makes the regulatory approval process (slightly) simpler and faster, but you still need to show that your treatment works. This is not easy and fast track and ODD doesn't solve this problem.
If you look through the scientific literature into oncoviruses, the problem has not been that they don't work pre-clinically, but they are very hard to deliver to the tumour in patients. If you can't get your treatment into the tumour then it doesn't matter how effective the treatment is in cells and mice. I am hopeful that someone will solve the viral delivery problem someday, but right now nobody has a good solution.
RAC Price at posting:
$1.34 Sentiment: Buy Disclosure: Held
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