There is reason for possible disparity between the pre-March 2022 COVID studies and the post-March Confirmatory Readout.
Data collection for the initial India study commenced August 2021 and completed November 2021. The US study was commenced in March 2021, was modified in November and then completed in the first week of January 2022.
The developed COVID Algorithm that is being validated therefore was based predominantly on data from the now nonexistent Delta viral strain. The Confirmatory study will be based solely on the Omicron forms, which didn’t appear in the US until early January.
If the Confirmation process is positive that will be a highly significant result. It would mean that the developed Algorithm is not sensitive to different COVID viral strains, including future forms.
This likely is the primary reason for undertaking the Confirmatory exercise.
