SiNtx Technologies Inc (SINT)

[OldYankee]

The biggest variable is the term “labeling”. I think it’s more likely that Sonny was referring to the 510K Summary that is required as part of the 60-day Substantive Review. Most people seem to think that the SE determination has already been reached and the label issue is just working out label information with a bar-code that gets slapped on the packaging; but I do not believe that this is the case. Instead, I believe that it’s the Summary information required for (not after) SE determination (Boston has also referenced this in some of his posts). This is why I still believe that there’s a 10% chance of an NSE. The Substantive review is 60 days, followed by 30 additional days to determine SE/NSE, then a 10-day administrative period; however, the clock stops with each “AI” (additional information) requested by the FDA. Per the PRs and CCs, I believe there have been at least two AIs. Amedica responded to one with 700 pages of data on 06/13/16. We also believe that the “labeling” AI has also been responded to (statistician phone call and perhaps AASSNNAAPP’s “Labeling is resolved” quote). As such, the only way an FDA decision can be this week is either FDA is aggressively ahead of their time allotment schedule, or the SE was already determined before the “labeling” issues. All of this is reflected in my previous timeline “chances” post.