Floridaorange
Oct 15, 9:29 PM
$NGEN “The functional results are encouraging, but less definitive."
Actually the functional improvements weren't isolated. They accompanied significant hand-MEP findings and other physiological observations, along with supportive exploratory biomechanical and patient-reported outcomes.
RESTORE was designed to address CONNECT's weaknesses
This is where your assessment is most incomplete.
RESTORE isn't simply repeating CONNECT with more patients.
It includes:
A functional primary endpoint based on the encouraging CONNECT hand-function results.
An FDA-aligned registrational design.
A larger, more statistically robust population.
A power calculation allowing a smaller treatment effect than CONNECT's observed difference.
Standardised assessments intended to reduce measurement variability.
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