SiNtx Technologies Inc (SINT)

[BooDog]

This is from the August filed 10-Q

We have received 510(k) regulatory clearance in the United States, a CE mark in Europe, and ANVISA approval in Brazil for a number of our devices that are designed for spinal fusion surgery. To date, more than 25,000 of our silicon nitride devices have been implanted into patients, with an 8-year successful track record. We have a pending FDA 510(k) submission for clearance in the United States of a novel composite spinal fusion device that combines porous and solid silicon nitride, and obviates the need for bone grafts. The FDA recently sent us additional questions about our submission and we are currently in the process of submitting a response.
https://www.sec.gov/Archives/edgar/data/1269026/000149315216012289/form10-q.htm

This is from June...

SALT LAKE CITY, June 13, 2016 – Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics, announced that it has submitted its responses to the Food and Drug Administration (FDA) in relation to the CASCADE clinical trial.



The CASCADE study compared the 24-month outcomes from single-level cervical fusion between Amedica’s porous silicon nitride versus bone autograft. Data showed that porous silicon nitride achieved clinical and radiographic outcomes that were comparable to bone autograft.



“Porous silicon nitride is a synthetic platform that can achieve spinal fusion without added bone graft, based on the results of our clinical trial,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “These outcomes are consistent with our understanding of the surface chemistry and nano-topography of silicon nitride. We believe the composite porous silicon nitride fusion device used in the CASCADE trial, if approved by the FDA, will improve patient health. We are confident that we have addressed the questions raised by the FDA.”



The Company anticipates a final determination from the FDA within the next 60 days. If approved, the Company would commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.

https://www.sec.gov/Archives/edgar/data/1269026/000149315216010753/ex99-1.htm

My mistake in my DD for not figuring out what they were talking about but one would think they would make it a bit more clear in their filing. Especially if they submitted a response already. I'm thinking they have a few more questions to answer based on the verbiage of the 10-Q.

Message in reply to:

The only thing I found was the FDA wanting info on the earlier stages of the trial which were answered back in June. I might have missed something but either way it's all a gamble. If people are worried about this being down 4-5 cents after it's gone up 100% probably don't need to be trading imo.

As for the "already up 100%" part I agree, there are always pull backs. I have a piece already and looking for more.