Cytodyn Inc (CYDY)

[Amatuer17]

HIV drug trial reality - somewhat old but more true now

http://www.bloomberg.com/news/articles/2011-03-14/gilead-s-high-bar-for-aids-drugs-means-new-development-withers

"There are very few HIV patients now who can’t find effective treatment,” she said in a telephone interview. “And it’s become extraordinarily hard to show you are effective in a treatment-experienced HIV patient.”
The development process was more productive around the turn of the century. HIV was evading existing treatments, like London-based Glaxo’s AZT and Merck’s Crixivan, and drug-resistance was spreading. Doctors and patients clamored for additional options, and clinical trials were in demand as the only way to get the newest treatments. A better understanding of the virus gave drugmakers numerous targets."

Drug studies are also taking more time to complete, said Norbert Bischofberger, Gilead’s chief scientific officer. The FDA now wants 48 weeks of data, and will ask companies to keep patients in the study for longer, up from 16 weeks initially, he said. Doctors want to see two or three years of data before putting their patients on a drug. European regulators have proposed extending the studies further to 96 weeks, he said.