2023 The Final Countdown, page-40

Hi @dachopper

I'm not exactly sure what your concern is here, but the restructure of OTAT within CBER has been in place & effective since September 16, 2022.

Mesoblast has been dealing with CBER on that basis since then, and I'm sure we all remember the resignation of Dr Steven Bauer and more recent intended resignation of Dr Wilson Bryan by March 2023. You can read about it here: https://www.biopharmadive.com/news/wilson-bryan-fda-retire-gene-therapy/641726/

The BLA resubmission has most definitely been lodged under the new administrative arrangements, and I'm sure that's part of the reason why Mesoblast held off in its filing.

Here's a link to the Fed. Register notice: https://www.govinfo.gov/content/pkg/FR-2022-09-28/pdf/2022-20997.pdf

...and here's the relevant content:




You'll note that Mesoblast is indeed dealing with the new Office of Therapeutic Products, and its administrative processes will be in a state of complete upheaval, no doubt.

That's one reason why I consider that, in a practical sense, there's very little to be gained atm in LTSHs speculating on timelines dependent e.g. on the inter-coordination of the new divisions.

Cheers