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General : ACUS View All Messages
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Recommend  Message 672 of 672 in Discussion 
From: Kutz  in response to Message 671Sent: 1/21/2009 3:36 PM
Al:  Oh well Cazador finally got his wish---LOL!  Nice analogy-this would have been more helpful coming out in November!  Pretty useless now and another monument of idiocy to Sherrie Oberg-the witch does not know how to time PR to even pump her own ticker.  If she would have submitted it earlier, it would have come out earlier!  God knows there was enough time!
 
If you were at the ACUS/FDA advisory meeting like I was, you would have thought Imagify was Mercury poision!  The FDA hosed this just that bad!
 
Now its work is in the most respected journal on Echo in the EU and the FDA will argue over clumping particles (do not exist-all negatively charged) and whether a efficacy study needs to be done to compare ECHO vs Echo/Imagify when the FDA never told them to do it, it not in their developmental guidence document, and its just plain stupid when you know you can not use Echo alone and get perfusion data-just wall motion!  How many tests must one do to verify common sense!  they created adverse event syndromes out of clear cut events that occur in patients using NUKE and occur even without Imagify administration in some patients.
 
The FDA is broken and theey BLOW-do not play them with your cash until they are reformed and that means throwing the entire entitlement crowd running the joint.
 
Until then, don't have a cardiac event or they will be giving you that radioactive material that must be safe for ya over particles with encased inert gas!
 
What a waste of medical science and money as US citizens pay billions more for NUKE procedures over the next couple-three years.  No wonder America is where it is-especially in healthcare!
 
Doubt this will do anything to its ground dragging PPS!?  Stick a fork in it!
 
Kutz