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12/11/06 01:21
Elmernot registered
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Phase III
The latest reports in the past few days indicates that Phase III has been dropped. Does anyone have further information?
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12/11/06 01:21
jim hnot registered
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Phase 3
My interpretation is that it hasn't been dropped, but was stopped because of a water contamination problem with the supply of AA4500. The trial is stopped until the problem is solved and the FDA gives approval to go ahead. I'm not an exper or and insider but I'm guessing this could take months. Whether the trial could be simply restarted after that time I don't know. If the delay is too long, it might invalidate the results already obtained and make it necessary to start over.
On the other hand maybe the problem can be quickly resolved and the trial will continue from where it left off.
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12/11/06 01:38
Donald 
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Phase 3
On Auxilium's website, there is a recording of the presentation made by Auxilium's CEO with respect to the Phase 3 potponement. He also addresses questions from the investment community. He said that they have informed the FDA, are investigating the problem and, once they are ready to resume the trials, will need approval from the FDA which, he says, takes about 1 month.
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