The only reason why I suspect they may be able to introduce some new data is because the MABs did precisely that in their re-examination (if you read their opinions), but it does appear on its face contrary to the guidance.
My guess: The “initial opinion” will be as of December 2025. The information allowed to be presented should be everything that the company has published in 2025 as long as it ties into the reasons listed in the re-exam request. My guess.
The ABCLEAR analysis was based on existing data that was submitted.
from homless Economist:
The only reason why I suspect they may be able to introduce some new data is because the MABs did precisely that in their re-examination (if you read their opinions), but it does appear on its face contrary to the guidance.
I dont think the data was new, the analysis was new. the data is the trial results from each patient. Wasnt ABCLEAR an analysis of a subset of this data? there was no new trial. So it should be oK