SiNtx Technologies Inc (SINT)

[boston745]

The submitter’s submission of a response to an AI request is an action that, upon receipt by FDA, resumes the FDA review clock, i.e., the 90-day review clock resumes upon receipt of the additional information.

This suggests that upon receipt of AI the clock resumes at the point AI requests go out. AI requests go out at day 60 suggesting 30 days remain.

Best case scenario is as follows:

June 10th submission + 60 days = August 8th + 30 days (AI request) = Sept 6th + 30 days = Oct 5th.

However if Asnaps assertion that labeling was resolved last Monday, meaning mgmt submitted late, we are looking at Oct 18th.