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Re: Hoskuld post# 508141

Friday, 11/14/2025 4:13:45 PM

Friday, November 14, 2025 4:13:45 PM

Post# of 517474
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

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