Cell Therapy News/Articles, page-17534

You cynic you. Haha.

I happen to agree entirely, especially from Marks (for getting between him & brown nosing the White House). It was interesting to read the email he sent to Janet Woodcock at the time about how he'd get people working triple shifts in OVRR to work faster to give approvals regardless of the time required to test contraindications, SAEs etc on vaccines for kids. He didn't mention names but Marion and Phil spring to mind, and Marks speech on their resignations was interesting too - said he was ''of two minds''. His hypocrisy knows no bounds, IMO.

Here's a good summary read for those who don't know what I'm talking about: https://edition.cnn.com/2021/08/31/health/fda-vaccine-officials-step-down/index.html

But I have to give a guernsey to Klinker and Bauer (because really only they could possibly understand mesenchymal stromal cells, in their own research, which they own, in their own little FDA lab empire).

It seemed a perfect storm for me, with researchers who shouldnt have been regulators because they were compromised and for them no amount of research would ever be enough for them to willingly give a recommendation to approve, & then a hungrily aspirational FDA Division director who had been set back while setting his sights on looking good for the C-suite politicians. I think that's really why Oppenheimer got the awards - it's true (and from Hollywood, go figure).

Just my personal view.

And yeah, this time round I also think we're up for approval. Klinker's no longer a mere CMC reviewer - now he's a Branch chief (Woohoo) and has to put his signature on the decisions and live with the impact of holding back life-saving interventions. He may have realised it will impact his own career. What goes around comes around. And now Marks is sitting next to the throne with his big, shiny new division (OTP). He can afford to be magnanimous when asked by the refreshingly principled Dr Verdun to do the right thing. Hey, now it''ll look good for the White House in an election year & he won't have to share the kudos.

Have a good one.
GLTAH