Hi @Lopez
you are such a suspicious person. Is this what you were thinking about?
I don't know how we can draw any conclusion from the mere fact that this anonymous 'philanthropic gift', received just before Hinrichs left the National Cancer Institute, was exactly the funding Hinrichs wanted to facilitate his career move & appointment to the role of Co-Director of the Rutgers Cancer Institute.
I mean, without it Hinrichs wouldn't have received his fabulous new salary or coveted role as Co-Director. Could that have been a factor in the 'gift'? Gee, let me think.
While we're at it, here's something else for Mesoblast holders to chew on. The passage below is extracted from the FDA's 'rigorous' review of the National Cancer Institute's application for marketing approval for selumetinib (KOSELUGO) in April 2020.
This shows exactly how "concerned" the FDA was about having rigorously proper historical controls in place for those single-arm trials they were considering approving:
" (page 21)....Additionally, a natural history study of NF1 conducted by the NCI POB was submitted with the application to provide external control data; however, no formal statistical comparisons were made by the FDA.... The natural history study was submitted to provide external control data;..."
Yeah. A natural history study that the FDA flipped through & thought 'looked good enough' - like Harper's Bazaar. Oh yeah, and it was put together by the National Cancer Institute (NCI) Pediatric Oncology Branch i.e. the sponsor. What could possibly go wrong?
That's the ONLY comment on external controls at all in the entire 344 page FDA approval summary. Link here.
Should make Mesoblast Ltd feel really 'special', eh? Imagine our surprise when we received the FDA's ODAC package.
Cheers,
GLTA(L)H
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