Genfit SA (NASDAQ:GNFT) Q2 2020 Earnings Conference Call - Final Transcript
Sep 30, 2020 • 04:30 pm ET
The data and what does this mean for Genfit I will then share or new strategic vision for the future and how new roadmap with translates into a new corporate structure and organization. Finally, I'll discuss the financial implications of this plan and our half-year perspective at the end of this call, you should have an understanding of what the coming years will look like for Genfit and then we will be happy to take a few questions.
Now, I will turn to the conclusion from our work on resolve it and the additional insights gained from the rigorous analysis, we've had on the full data as a reminder, the first objective of this data review was to take an in-depth look at the complete data set analyzed histology findings, as well as biomarker evolution and assess whether there was justification to believe that the study could ultimately prove successful on clinical outcome. We also wanted to explore the potential of elafibranor in subpopulation although we did see evidence of activity. We did not see enough to justify continuing the study with a high probability of success. Similarly, we observed positive trends and a stronger response in specific patient growth but not significant enough to justify investing in a new development program.
Our second objective was to have a second biopsy conducted with a renowned is so pathologists. We were committed to having a better understanding of this topic, because we are realize how important it is for the whole NASH community to understand the implications of viability to date, a sufficient number of biopsies REITs have been performed which has permitted us to meet 2 objectives first complement the existing datasets and inform internal decision making and secondly address questions related to reader viability.
At the end of the day of filings Vos from study described in a paper recently published in the Journal of the pathology which concluded that the suboptimal reliability of liver biopsy evaluation has implication for randomized clinical trials in the context of resolve it the copper values were too low to draw any specific or new conclusion about the trial outcome and certainly nothing that we could use to support this About H approval for statistics only confirm that into a bit viability is a real concern and we look forward to discussing these findings, along with the rest of the rest, the data with the FDA and the EMEA moving forward as stated, but it is a bit brunch in an article from the same issue of the journal, if a pathology.
We believe it will be important for the field to harmonize methodologies Seminole and expectations for trial assessments beyond the additional analysis of data or decision to terminate resolve it also factored in the latest NASH development. We consider the FDA's feedback regarding the over-completed Phase III NASH program as well as new data from several ongoing NASH programs and we feel confidence we made the right decision. Indeed clinical trials