- Re Halabi - Yes, but she was 51/49 as she stated - and agreed - from everything she was particularly in the first half of the day talking about, I expected her to go the other way. So - one who voted no (Hinrichs) and one who almost did (Halabi) - they're the ones I'm drilling down into re what their basis of reasoning was, and why it was - and therefore what resultant conversations they may have therefore had with the FDA. Everyone else was a clear and strong "yes" as far as I could tell.
I note there's a pile of articles and tweets on the twitterverse already, either about this outcome, or direct to the FDA.... so - it's begun.
Example:
https://pharmaphorum.com/news/fda-issues-shock-rejection-for-mesoblasts-ryoncil-in-graft-versus-host-disease/
If you're on twitter (I'm not, but am contemplating it, because I'm THAT shocked) - could be good to like and comment on the articles and tweets you support.
Even if you're not a supporter of Mesoblast, but are a supporter of stemcells - because as one stem cell lab tech noted a couple of days ago "this affects us all".
Ryoncil: ODAC/FDA Meeting Discussion, page-2047
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