Australian newspaper article, page-169

Hi again Reg,

I think I've posted previously that the part of Dr Klinker's dry-as-a-biscuit monologue which I found most instructive was at 10:03 in, where he says (altho'its mangled in the audio transcript), when describing the FDA's "NEW APPROACH" this little gem:

" ...While this new approach I've just described is certainly broader, it is also more flexible.

If there are limitations in one aspect of your potency assurance strategy, other aspects of the strategy may be able to compensate for those limitations. (!!)

For example, for some products the potency-related CQAs might not be well understood ( hmm...that sounds like familiar criticism for some reason ) or may be or might be difficult to measure reliably ( hmm....I seem to remember these criticisms being made about a certain product...now what product was it now... ) .

And as a result lot-release testing may not be able to fully confirm product potency. ( huh...but that's ....us... that's exactly us...RYONCIL!! And you FDA wouldn't accept it as 'confirmed' to your satisfaction before now. )

But other aspects of the potency assurance strategy, such as process design and control (like the process design confirmed by the inspection FDA failed to schedule for RYONCIL at any time before May 2023), can take on increased importance in these cases, and be made more stringent and extensive. ( I don't remember this option ever being offered to RYONCIL before September 2023!! )

THIS ADAPTABILITY IS ONE OF THE KEY STRENGTHS OF THIS NEW APPROACH ( Wow....how far has the FDA come from its strident, self-righteous & narcissistic obsession with its own conflicted research & blinkered insistence on potency assays as on display at ODAC) "

For those who don't remember August 2020, here's Matt the Mouth in action, barging into the PM session & trying desperately to shoot RYONCIL down in front of the ODAC panel:





I don't see Matt cutting RYONCIL or Mesoblast any slack here. Link here. This is proof - to me - that the FDA had no interest in "adaptability" or "potency assurance strategies" (as distinct from assays) until 2023.

Change of heart? I'd say, what heart? And lets not mention the kids. Thank God Dr Verdun is there now.

Cheers