MSB Trading 2021 - paradigm shift, page-9158

@stocksa, thank you for posting the article. While better minds than mine can argue over whether these drugs should have been granted AA in the first place, I read the article as the review meeting was cancelled as there was nothing to review. The companies (Novartis seem to have done well to dump their interest) have failed to meet the requirements of their AA's hence the question of cancellation being referred back to them. I expect result of the discussions with the FDA will be made public in the usual way.
When you had AA granted for these and not for SRGvHD is however a black flag on the internal management of the FDA at the time of the decision.
This has been well discussed oh this forum already.
The OTAT agreement over potency could have been part of our AA given that we had evidence of efficacy (Japan) our own limited trials and that it had no discernible side effects. Here's hoping that this cancelled meeting will give bandwidth within the FDA to get on with the work that we need for our therapies.
Its now December, tick tock, FDA, time to unlock!
regards
Yelrom