Quote:
Originally Posted by tadd
Rick:
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Most Pharma only carries a drug the last mile (phase II/III clinical trials). One should also note that the role of government has been reduced in clinical trials to overseer. Pharma pays its way anymore.
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Actually the Pharma company is responsible for all 4 phases. A university may do phase 1 studies as those are much smaller studies and are focused on dose ranging and tolerance rather than efficacy. But the cost of the NDA will be borne by the company. Currently the PDUFA filing fee is $2.1 million.
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