The question posed by Matthew Katz concerning indemnification has
interesting implications.  My position in response to his question is yes
for all company sponsored studies, because it is simply good business
practice.  Any  delay should not present a problem, because the drug is
already approved and available clinically.

 However the more intriging part to me is why the study should be done
at all if the drug is already approved by FDA.  Obviously I have no facts
nor insight into the specific case.  However, depending on the proposed
study, I could envision situations where the IRB might feel uncomfortable
in approving the study as being overly redundant or not necessary.

 A remote but related example might be whether it is ethically sound to
conduct a study of the efficacy of drug B in comparison to a placebo when
drug A is already approved and a clinically acceptable treatment protocol.

Terry A. May, Ph.D.                       Voice:    520-523-6788
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