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banter and General Discussion, page-10536

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irenekwshiu

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17/08/24

08:29

Post #: 75248674
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Originally posted by Phaedrus: ↑

Hi Reg,

I think Matt Klinker’s face has put on a lot more weight since his LinkedIn photo was last updated - I say that having reluctantly viewed ‘Matt the Mouth’ & his unviral wannabe-influencer video, currently running on the FDA site.

And that’s a good thing, IMO.

Someone thinks Matt can be the, or at least a, poster-child for FDA’s policy-sharing informing & industry updating role on HCT/P at CBER - possibly his besty, Marks, or Verdun.

But why do that? These standing information videos on FDA’s official public site are as rare as unicorns.

I have a couple of ideas. The one I like most is that CBER wants Matt to be a lightning-rod for administrative acclaim or censure on the potency issue, especially for HCT/Ps. IMO he came into cellular therapies at FDA with an arrogant belief in the primacy of his own research, worked with Bauer in his horribly conflicted FDA research labs.

And then - by setting bars in the clouds & taking away the ladders - contributed to CBER holding back on anything to do with ‘stem cell’ therapies for ages.

This cost America in many ways, all of which the FDA can try to ignore. But as bureaucrats they can’t ignore increasing BLAs in their inbox and they can’t ignore the industry funding under PDUFA, & their statutory obligation to provide guidance on how to satisfy CRLs.

So, Matt gets a promotion after the ODAC debacle, but the condition is that he has to put his name to the new full message I.e. that FDA can be flexible. On potency. And there he is in the video saying things that he never said at ODAC in the PM session which he so rudely interrupted.

And his face is a bit heavier. Welcome to the real-world Matt.

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War and er, will there be peace, that’s the big question then?

MSB Price at posting: $1.01 Sentiment: Hold Disclosure: Held
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banter and General Discussion, page-10536

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