[Edaily Reporter KIM SUNG-JIN ] Voronoi, Inc. avoided providing specific details regarding why only 8 out of 15 patients in the C797X variant patient group were included in the efficacy evaluation. The company also did not disclose the timeline for releasing additional data on the C797S patient group or the current status of patient enrollment in the expanded cohort in this response.
On the 3rd, when asked about the number of patients excluded from the efficacy evaluation by reason and whether there were any overlaps, Voronoi, Inc. replied, “This is detailed data that has not yet been disclosed at academic conferences, so it is difficult to comment on an individual basis.” Consequently, the specific reasons for the exclusion of the remaining seven patients remain unknown.
Regarding the possibility of future evaluation for the NE (not evaluable) patient, the company explained, “Although SD (stable disease) was confirmed at the first tumor assessment after dosing, the next imaging evaluation date had not yet arrived at the data cutoff, so a follow-up assessment was not conducted.”
Regarding follow-up data for the C797S patient group, the company stated, “Specific items for the update have not yet been finalized,” adding, “As additional data is accumulated, we will review the information to provide a comprehensive update on efficacy and safety within the scope permitted for disclosure.”
The company also stated that it is difficult to disclose the current status of patient enrollment and dosing in the expanded cohort. The timing of data disclosure and plans for conference presentations have not yet been finalized and will be determined based on the progress of the clinical trial and the extent of data accumulation.
The company stated, “We are well aware of investors’ disappointment and concerns regarding the stock price trend,” adding, “We are doing our utmost in the clinical development of our key pipeline and global business development.”
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Voronoi, Inc. avoided providing specific details regarding why only 8 out of 15 patients in the C797X variant patient group were included in the efficacy evaluation. The company also did not disclose …