I'm not sure whether you've discussed it more on other threads or not, but I figured it would be interesting to hear more your thoughts about this as I think we might be on the same page here.
Essentially, MSB were unable to get approval of Rem-L in paediatric Gvhd. This was/is due to the current clinical trial data being not being adequately controlled and related potency assays were not sufficiently related to the mechanism of action.
However, as I read it in the paper, SI walked into the latest meeting with the FDA and was told "actually, we’ve thought this through, and you’ve convinced us that the clinical data are very strong."
This is...weird. Why would the FDA assess this twice, come back with the same outcome both times (you need to do another well-controlled trial), but now backflip and essentially admit their previous two assessments were wrong? My best guess (and I have put no effort into researching this), is that there is a new person assessing regenerative therapies at the FDA. They are of the opinion that a trial can be "adequately controlled" with no control arm in conditions where survival outcomes on standard of care are low. This flies in the face of the FDA approval process, but short of suggesting something criminal has occurred, or that SI was just talking out his backside in the article (which I guess would also be criminal), this is the only way I can see MSB as having gotten a green light to proceed without another clinical trial.
What are your thoughts?
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