Mar. 19 at 6:02 AM
$RGNX More heat on the FDA today, this time from the MPS Society.
https://www.fiercebiotech.com/biotech/rare-disease-advocates-stage-funeral-fda-demand-4-actions-agency-and-congress
But that controversial FDA spokesman that they are calling "Scientist Andrew" again is saying they are requiring a "well-controlled" (i.e. placebo) trial.
“The FDA is diligently committed to delivering cures and treatments to families in need in the safest way possible,” a spokesperson for the Department of Health and Human Services told Fierce. “That means requiring clear evidence of clinical benefit for the intended patient populations. Companies must demonstrate that benefit through strong data from a well-controlled and adequately-run clinical trial.”
