This week's Biotech Scorecard newsletter: The FDA is a mess, but don't blame it for everything
I write about $QURE and $BHVN
Re: Uniqure and its gene therapy for Huntington's disease, the dissonance between the FDA's words and actions can be confusing.
Approving AMT-130 seems like a no-brainer win for the FDA and the policy initiatives pushed by its leadership.
The reversal certainly has Prasad's conservative data-stickler fingerprints all over it, BUT...
You have to consider the possibility that there is a significant issue with the AMT-130 data, the composition of the external control group, or both, that Uniqure hasn’t disclosed.
Slingshot Insights hosted a call Tuesday with an HD physician who was critical of the AMT-130 data, saying the therapy was "far from ready for approval."