The FDA’s refusal to file letter surprised analysts. The note from the regulatory agency had to do with the date when the manufacturing site would be ready for inspection and a question about the submission of the drug master production record, Acorda said.
The move is “surprising, puzzling, disconcerting” and “a very significant surprise,” Leerink analyst Paul Matteis said, according to MarketWatch.
The Ardsley, N.Y.-based company said it believes that the issues are “addressable” and pointed out that the FDA has not asked for more efficacy or safety studies for Acorda’s Inbrija.
In March, the company touted data from 2 ongoing, long-term safety studies of its inhaled Parkinson’s therapy. The trials showed no difference in pulmonary function between the group receiving the inhaled formulation of Parkinson’s drug levodopa and the control group.
Inbrija is being developed as a therapy for people with Parkinson’s disease experiencing “off” periods, or a re-emergence of symptoms.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.