Don't forget that on-site inspection in the deep midst of the pandemic would have been too hard.
Now - it's a different story, as the borders are opening up.
What I'm hearing though, is more concise and clear of what to be expected of the BLA Resubmission for Ryoncil:
- OTAT will review the QA data. "Mesoblast will provide these new data to FDA and address all other outstanding items as required for resubmission of the BLA"
- Site inspection will be within the 6 months BLA PDUFA date
- Approval expected in 2nd half of this year
I was having a guess earlier in the year, and see no need to update this timeline.
https://hotcopper.com.au/posts/58596424/single
"So, all up 7-9 months, Q3 2022 for commercialisation?"
We are two months in, so I'll would expect 5-7 months to go, Q3 2022 for commercialisation?
Bring on with the BLA resubmission for Ryoncil!
Somewhere between March and April 2022 is still my expectation, the sooner the better of course.
GL MSB'ers
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