They could be continued on the basis of efficacy studies in experimental animals and existing data in humans.
The requirement that new efficacy studies be initiated sets the company's marketing efforts back by about three years.
Comparison of published, placebo-controlled efficacy studies of at least six months duration (abstract).
If this treatment is not too dangerous, efficacy studies will begin involving hundreds of patients.
Nastech has completed two safety and efficacy studies in men, and the second study in women is currently under way, the company said.
It also stated that the medical literature showed "little evidence regarding liver transplantation in H.I.V. patients and no well-designed safety or efficacy studies."
"When insurers say there are no efficacy studies of liver transplantation for people with H.I.V., that is an absolutely true statement," she said.
An efficacy study of itraconazole in the treatment of Penicillium marneffei infection.
We conducted a meta-analysis of the results of efficacy studies and of the drop out rates.
Comment: I was part of an efficacy study 9 yrs ago.