Biotech industry and investment community should get "used to" not-approvable letters, two execs say.
Executive Summary
BIOTECHNOLOGY INDUSTRY SHOULD GET "USED TO" NON-APPROVABLE LETTERS, Athena Neurosciences CEO John Groom told investors at the Twentieth Annual Alex. Brown Healthcare Seminar May 18 in Baltimore. "I think we as an industry have to probably get more used to non-approvable type letters," Groom suggested. Such a letter "doesn't mean to say the drug won't be approved," Groom told the investment meeting. "It means to say that you have issues that you have to deal with the FDA."