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Re: reg2015 post# 76082

Saturday, 09/24/2016 2:48:09 PM

Saturday, September 24, 2016 2:48:09 PM

Post# of 818066
"there is no sense in giving anyone else something that is not working"

If you were right and the FDA put the screening hold for this reason why would they even bother to ask the company to provide certain documentation ? If it had failed then it had failed what good would documentation do ? sorry I do not buy into this theory also. I believe they are waiting for events to reach pfs and the longer we do not get results the better. I personally believe it is a 'red herring' the issue of screening halt. The patients continued to receive the drug another reason why your theory does not make sense. Surely if [over a year ago] the decision you say was made then FDA would not leave patients receiving a drug that they found had failed.. They would want the patients to be free to try other treatment options. I do not believe the screening halt has anything to do with either efficacy or futility.
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