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Re: boston745 post# 5624

Tuesday, 08/09/2016 10:37:32 AM

Tuesday, August 09, 2016 10:37:32 AM

Post# of 42671
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
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