A startup biotechnology company out of Yale University is concerned that the government shutdown will have an impact on a new drug they’ve been working on.
ReNetX Bio, Inc. said it’s developed a breakthrough therapy that could help restore function in patients suffering from spinal cord injuries, stroke, and glaucoma. And the company was right on the cusp of submitting the drug to the U.S. Food and Drug Administration for review when the government shutdown happened. It’s the last step before clinical trials can begin.
But since the shutdown, the FDA is not accepting any Investigational New Drug applications. Company CEO Erika R. Smith said that could have a far reaching impact.
"You know, that could affect a lot of things," she said. "We’re working with clinical sites to do the work. They’re only going to be ready for so long. The material has a shelf life so that will only be ready for so long. Our company is a small company. We only have so many funds to make sure people’s salaries are paid. That’s the internal piece, but the patients that come to us and say, ‘We are looking for a solution.’ That’s the broad piece that we are concerned about."
Smith said they were hoping to begin clinical trials by May, but they can’t move forward without FDA approval. And once the government reopens, she said there’s no way to tell how the backlog will affect them.
Smith met with Senators Richard Blumenthal and Chris Murphy at the company’s New Haven office. She told them they’re trying to come up with a backup plan, which could mean looking outside the U.S.