It would be nice to see some update on the progress of pixclara resubmission in this quarter.
Based on what CB said below...
"While the FDA’s CRL requests additional clinical evidence, we believe there may be a pathway to resubmission in late 2025 or early 2026, pending further discussions with the agency"Hopefully retrospective data telix already holds is sufficient to meet what FDA is after?But sounds like.....
The FDA has often been reluctant to accept retrospective data as fully equivalent to a prospectively designed Phase 3 study—especially in imaging—but it sometimes does if the data is of high quality, independently verified, and statistically powered.
fIngers crossed...
cheers
S
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