Prediction of , index 320
Prospective Prediction
- Prediction Index
- 320
- Prediction Date
- Commercial Prediction
- FAILURE (commercially insufficient clinical benefit)
- Technical Prediction
- FAILURE (statistically insignificant clinical benefit)
Readout of
Prediction Validation
- Readout Date
- Prediction To Readout
- 85 days in advance
- Readout Data Interpretation
- efruxifermin achieved borderline statistical significance in 50mg but not 28mg group with 17% placebo-adjusted reversal of cirrhosis with no worsening of NASH at week 96 in the IIT analysis (p=0.031). Caution- it is rare to have an “randomized” distribution of 47 missing-biopsy population among the placebo/28mg/50mg groups (30%/39%/37%) that’s out of proportion with respect to the differential distribution of 19 TEAE-treatment-discontinuation patients among the placebo/28mg/50mg groups (3%/11%/18%). Using proportional-to-TEAE-discontinuation distribution of the 47 missing-biopsy population (9%/34%/56%); then the resulting IIT analysis would be around 14%/21%/25%; becoming statistically insignificant)
- Press Release
- Press Release (globenewswire.com)
- Additional Readout Data
- Add'l Clinical Benefit Comparison Data (finance.yahoo.com)
Prediction Result
- Prediction Accuracy
- Unadjudicatable Prediction
- Clinical Benefit Conclusion
- statistically probably significant (depending on IIT analysis methods) and commercially TBD; phase 3 trials are required to adjudicate this prediction especially given that our ex-ante prediction of the same trial at its 36 week primary endpoint (2H23 Batch 14 timestamped on 19Jun2023) has been validated to be correct (see add'l link below)
- Prediction Classification
- —