The FDA has asked Novartis for more information on its meningitis vaccine Menveo, which is likely to push back any approval date to late this year or early in 2010. And the manufacturer was quick to note that the agency is focused on questions regarding production, not safety or efficacy. That means no new clinical trials are needed to satisfy the agency's request.
It's a setback for Novartis, but not a serious obstacle. "While the financial impact is small, the setback is nevertheless a disappointment," said Vontobel analyst Andrew Weiss. But with prospective annual sales of $650 million, any delay is likely to sting. Menveo has demonstrated it can guard against the four most common types of meningitis.
- read the report from the Wall Street Journal