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dolphinsmike

06/01/07 9:02 AM

#1919 RE: exwannabe #1918

Once again i will say, when you have data (raw or in any format) and send it to a company that has a software that reads any format usually PHP OR ASP. it is a simple process. data mining (interpretation) on a working software platform is easy. guys listen to what i am saying PLEASE! think about it for a second. once a coded system reads datat it is the job of the software to take raw data, and then create a story out of it. the story is made on the way the system is supposed to read that data. either the system f'd up or the data was f'd up. it cant be both. my other concern is this. if the data was correct more than likely the system would have been able to read the data. usually when errors occur it is the format of the data, or the way the data was created, supplied, or handled. i can assure you that any company that reads data, has strict guidlines on how they must recieve the data, example would be, the order of fileds. that list is different depending on how the software works. my other thing is this, if the data was wrong the system would have recognized this immediatly. and when i mean immedialty i mean from that very secon the data is loaded. it would not be a delay of 30 days or 60 and now we do not know how long it will be. bottom line someone screwed up, and both sides are going to point the finger to one another. and the way last nights PR was read clearly shows that both sides are being very sensitive to one another. which again is usually how it goes in the data business. remember data is so valuable, taking yoru data to someone else isnt something you want to do. now 2 independant companies have your KEY COMPANY INFORMATION and nboody wants that floating around. and nobody can ever tell me, that data does not get swapped, sold, traded, stolen etc.... so its better off being at one place, being respectable keeping the foul up quiet so both parties can try to figure this mess out.
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beachgal7711

06/01/07 9:07 AM

#1920 RE: exwannabe #1918

As I said in my previous post, the FDA will also check for errors when the NDA is submitted. If the stat sig results from these errors, you are in trouble with your NDA. Of course, if no symptoms in either arm were the result of the trial in 1500 subjects in 27 centers, that would be extremely odd and I cannot believe that happened. That it happened in some centers, enough to screw up the trial, is the downside of allergy trials and will force them to somehow do another trial. What it does not do is give any information on the efficacy of what is being tested, in this case, PreHistin.