Jul. 31 at 12:00 AM
$CLNN I asked Claude to provide a summary of the recent CAPR and REPL adcoms and any read through for CLNN. Here is what it spit out:
$CLNN — the CAPR/REPL adcomm split, and why it matters for our ALS accelerated approval thesis
This week gave us a rare natural experiment: two adcomms, same FDA committee (CTGTAC), back to back, opposite outcomes. Worth unpacking in full because the read-through to
$CLNN is more specific than "biotech sentiment good/bad."
$CAPR — voted down 9-3 (Wed 7/29)
Deramiocel for DMD cardiomyopathy. This wasn't a case of thin data getting punished — patient and family testimony was described as "moving," and the panel even found some encouraging signal in upper-limb function data. What sank it: FDA's briefing docs argued the efficacy claims leaned on a statistical analysis plan that looked assembled after the company saw favorable results, not one locked in advance.
