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Alias Born | 07/17/2006 |
Monday, September 22, 2014 5:49:29 AM
I absolutely agree the SPA meets all criteria for a contract, hell this is for $100mil, its written, and its binding..For Christ sakes it was put together by congress. Agreement my ass.
IMO the whole idea at this point to drop the appeals with two more to go (there were never more than 5 levels) is the height of stupidity. The FDA wants to go down this road..fine. The FDA has already showed us its attitude towards a "dog that doesn't bite back."
The FDA's position, its arguments in this matter are obtuse and absurd. If its lawyers have really signed off on this charade then they must be morons. Let them send us a CRL, if they have the guts. What is the CRL going to say other than what the the FDA has already spewed already. They do not think lowering trigs will lower CVD risk..Hello JELIS, Hell, the president of the lipid society testified at the AdComm that in his opinion trig lowering was important.
The FDA has not only illegally breached the SPA contract they are going up against the lipid society's position in this matter. Remember the FDA is suppose to be taking these society's clinical advice and not vice versa. So who's opinion is the FDA taking?..Guess it must be AZN's..That's what going to come out in court.
":>) JL
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