Apr. 2 at 1:47 PM
$CLNN As this is certainly a stressful time for all of us as we await the results of the Type C meeting, I thought it would be useful to compile a summary of what I think are the most important points here:
1️⃣ FDA already guided CLNN toward an NDA path.
This Type C isn’t about debating efficacy — it’s about aligning on confirmatory-study design and the final NDA package. FDA doesn’t schedule this type of meeting unless an NDA could be viable.
2️⃣ The data is prespecified, not cherry-picked.
All the key signals come from prespecified statistical analysis plans — not a post-hoc fishing expedition. That matters enormously to FDA reviewers.
3️⃣ NIH put
$45M behind this program.
A massive, multi-year NIH grant helped generate the dataset CLNN is presenting. NIH doesn’t commit
$45M lightly — and the agency knows that. It adds independent credibility to both the science and the rigor.
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