I’m not sure if it’s been posted before but for anyone curious about when we’ll be hearing updates on the approval of Ryoncil from the FDA here’s a few rough pointers based on the process:
- The application for Priority Review can take up to 45 business days for the FDA to decide on. If it took the full 45 days to approve priority review, that would take us to April 3rd.
- If successful for Priority Review, the product approval itself is shortened from a 10 month window to a 6 month window. Meaning at the latest we should learn of product approval in July.
A 6 month approval timeframe was the average time it took the FDA in 2018 for Priority Reviews after receiving the final parts of the application, so in 2020 hopefully it will be faster than this, but good to keep in perspective!
As for what the SP will do in this time, it’s anyone’s guess without news. It’s still currently a lot higher than it was a month ago!
I’m not sure if it’s been posted before but for anyone curious...
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