I thought this was a very interesting interview of Woodcock:
https://www.outsourcing-pharma.com/Article/2021/05/18/FDA-leader-stockpiling-could-boost-clinical-trial-system
So she's proposing building a national clinical trial network/stockpile to speed up the trials, because as she notes in it that despite tens of thousands of people dying, they had trouble actually enrolling people in the trials. The article then notes that with cancer only 3% to 5% are actually even offered the chance to participate in trials (I think this was the thing that shocked me the most).
So the lengthened timeframe and people skewing off track re the trial perameters for restemcel is it a MSB specific problem? Not at all - its a general problem, which the Commissioner recognises and is actively seeking to fix.
There is something very sick, about the American health system, was my takeaway from this.
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