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According to a consultant another company was also told by the FDA that 2 facilities need to be inspected. The inspection of the supplier never happened. FDA didn't tell the company anything, but approved the product on PDUFA.
Stay with me...
According to a consultant another company was also told by the FDA that 2 facilities need to be inspected. The inspection of the supplier never happened. FDA didn't tell the company anything, but approved the product on PDUFA.
Stay with me...
I searched through the reviews of recent approvals.
Novo Nordisk's Sogroya (growth hormone) got approved on 8/28/20 without an inspection of a facility. Facility has never been inspected before. Inspection was waved based on a risk/benefit analysis. No breakthrough designation.
Novo Nordisk's Sogroya (growth hormone) got approved on 8/28/20 without an inspection of a facility. Facility has never been inspected before. Inspection was waved based on a risk/benefit analysis. No breakthrough designation.
A few days later (9-3-2020), the FDA approved Detectnet. In that case, the FDA couldn't visit the manufacturing site due to Travel restrictions. It performed a "desk review" and approved.
Those 2 cases prove to me that the FDA is willing to show flexibility that can range from desk reviews to full inspection wavers, even if a facility was never inspected before.
I might be crazy, but I'm personally back at 80% likelihood of approval by/on PDUFA for liso-cel.
I might be crazy, but I'm personally back at 80% likelihood of approval by/on PDUFA for liso-cel.
