Replies to post #5624 on SiNtx Technologies Inc (SINT)

[TennisStar]

Yes Boston What's the hold up? Dr. Bal what is the hold up?

1) The FDA
2) OUS Trial
3) Si3N4
4) Declaration of Helsinki
5) "If a sponsor is planning to use exclusively OUS data to try to win PMA approval for a device, they are encouraged to meet with FDA officials before making that PMA submission."

Number 5 is the key. Additionally the opinions floating being express that the device is a sure thing to gain FDA approval are so off target. It's the US FOOD AND DRUG ADMINISTRATION, there are no sure things and in fact run a statistical model on pre market approvals based on outside the U.S. Data.

Oh that's right Mr. Houston stated they have been discussing an insider stock purchase plan. LOL