SiNtx Technologies Inc (SINT)

[vonLampertheim]

For the record and the sake of posterity, I do not believe my narrative in post 7048 is still valid after much research/discussion/contemplation. In looking at how the FDA is addressing labeling in general, the process looks more more fluid and interactive than I gave it credit for, and trying to match up the exact status of the ongoing dialogue with the movements in the process isn't the right approach. In my last post #7177, I showed how the FDA is missing its own published PDUFA dates with regards to handling labeling issues that in the FDA's court, despite the drug being recommended for approval in August. The back and forth between the company and the FDA will take as long as it takes, and the FDA gives zero consideration to the commercial impact that the process inflicts on the company while it seeks approval---that is simply a burden that management must handle with every resource at its disposal.

I'm returning to my originally stated understanding that that the Company received an AI request on or around the Q2 conference call of August 11 and the company has 180 days to respond per the 510(k) process. I would encourage everyone interested in CsC approval to read the link below as it spells out the exact process in plain English, and it is clear to see where we are in the overall process.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

Specifically:

Additional Information (AI) Request

If the Lead Reviewer sends an AI Request, the submission is placed on hold. The submitter has 180 calendar days from the date of the AI Request to submit a complete response to the AI Request. Note: The response must be received in the DCC within 180 calendar days of the date of the AI Request. No extensions beyond 180 days are granted. If FDA does not receive a complete response to all deficiencies in the AI Request within 180 days of the date of the AI Request, the submission will be considered withdrawn and deleted from our review system. If the 510(k) is deleted, the 510(k) submitter will need to submit a new 510(k) to pursue FDA marketing clearance for that device.

It is also important to note that each AI carries its own 180 day response window, which is not extendable. The above quote makes it pretty clear what is allowed under the AI provisions and where we are in the overall process.

If the company confirms submission of the AI request on or before February 2017, then we are still in process and everything is "on track" and we are back to waiting on another AI or a MDUFA decision. I have industry experience with this taking much longer than anticipated while everything remains "on track" for approval. Any speculation to the contrary, positive or negative, without confirmation from the company is simply that: speculation.

I now believe the next approval we will see is for the updated pedicle screw system. On the Q1 CC, the company had stated its intention to have this approval in place for a soft launch at the NASS conference later in October, but without guidance from the company, we don't know when they filed and when a response is expected. Fingers crossed that it lands before the NASS conference and we get a positive catalyst going into the 10 November earnings call. The Shareholders can use some positive news, and the pedicle screw system would double the company's revenue per procedure when used with their implants.