Agreed.
But I'm not surprised considering that Joanne Kurtzberg is one of their medical advisors. She was present back at the ODAC meeting in 2020, and I think she'll have been at everything that she can be ever since. I wouldn't be surprised if she championed the support for the confirmatory Phase 3 in adults to be performed by the BMT group.
Something that I just had a look at and am now bemused:
Our old mate Steven Bauer is a director at the BMT group. He's the one who was the Branch Chief of the Cell and Gene arm when we first submitted in 2020. It was he and his team that kicked up all the fuss about potency in the first place.
I wonder what he thinks these days and what all the relationships are like.
With the Chair of the FDA, Robert Calliff, being from Duke and also working with Joanne - this whole thing just seems very inbred.
Cell Therapy News/Articles, page-17267
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