So the thing is, I can kind of understand what you're saying if you're looking at RWE for Remestemcel-L as a layman, and if you don't understand the medical field.
You look at each case and go "so what, a complete response and full recovery from SR-aGVHD, what difference did Remestemcel-L really make. Besides, it's an N of 1".
Luckily you aren't the target market for the product.
Doctors read these studies and understand the nuances. They understand how big of an issue the high risk of severe opportunistic infections and risk of relapse of malignancy is for kids with SR-aGVHD.
They know how rare it is for someone with a severe case to survive. They know what typical results look like and can see the difference Remestemcel-L makes.
This is how a new product enters the field. Real world evidence, case reports, word of mouth, direct sales with reps present in treatment centres - at least for complex cases Rem-L's IV delivery is so simple this may not be required.
So while you may have a bit of an understanding of levels of evidence, you don't understand the industry.
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