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Couch

04/25/13 2:10 PM

#53272 RE: bearmace #53270

NDA opioids that are 5052b and do not require Full Phase III trials.....6 - 10 months.....6 being fast tracked....10 months beings standard...

Andas.....probably around a year and a half. Sometimes shorter.
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lasers

04/25/13 2:14 PM

#53275 RE: bearmace #53270

Depends on the background of the intended drug, similar drugs on the market, society's need of such a drug, extension potential of a person's life, etc, etc. Many many factors goes into the trial details required all of which affects the approval time factor.