Stromedix, with Biogen Idec Roots, Seeks Exit from Regulatory Limbo
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great,” he says. “I feel better than before.” Not one to keep his condition secret, he kept of blog of the experience on the public Internet, and he frequently makes personal comments on Twitter under the alias “wristshot.” (Yes, Gilman, a native of Canada, is a hockey devotee.)
Gilman is also optimistic that the FDA will allow his firm’s kidney fibrosis study to move forward, perhaps in the first half of next year. His company, which has raised $29.4 million in venture capital since it launched in 2007, will need more support from venture investors to fund the trial. “We’re pretty psyched because we spent the last year a little bit in limbo, which is frustrating for me and the team, and I would say anxiety-provoking for the investors,” Gilman says.
While Stromedix’s efforts have been delayed on the kidney front, the FDA has given the six-person company permission to start mid-stage clinical studies of its drug for a lung disease called ideopathic pulmonary fibrosis. Gilman explains that the agency’s safety concerns about the drug were specific to recipients of kidney transplants, and the agency does not have the same concerns about its safety in patients with lung fibrosis. Still, Gilman declined to provide specifics about the agency’s safety concerns for the kidney group.
“I probably shouldn’t say what their … Next Page »