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