Whatever.
Meanwhile, some more formal analysis of why many have been discussing the evidenced change in the wider regulatory landscape change at the FDA (as demonstrated by Peter Marks' seminal interview) to give a little more optimism on MSB's resubmission, beyond its individual merits, as well discussed:
https://www.propharmagroup.com/thought-leadership/illuminating-fdas-2023-bla-approvals-a-comparative-analysis
"Conclusion' In summary, 2023 showcases significant strides in biologics, offering groundbreaking solutions for complex diseases. While safety, accessibility, and ethical considerations remain paramount, the FDA's dynamic approach and commitment to innovation set the stage for a promising future in shaping healthier lives."
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-578
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