SiNtx Technologies Inc (SINT)

[OldYankee]

For kicks, I modelled 10 scenarios based on information to date. The probability result of the timeline scenarios for FDA clearance are as follows (per my calculated assumptions for entertainment purposes only):
9/26 to 9/30 = 10% chance for SE (FDA Substantial Equivalence clearance).
10/3 to 10/7 = 20% chance for SE.
10/10 to 10/25 = 50% chance for SE.
10/26 to 11/18 = 10% chance for SE.
NSE (Not Substantially Equivalent / not approved) = 10% chance. In this scenario, CsC would not qualify for 910(K) clearance due to differing data points (related to bone growth) between CsC and PEEK with Bone Auto-graft (the submitted “predicate”).

The dates indicated would be when FDA notifies Amedica via emailed letter, not necessarily when a public announcement is made.