banter and General Discussion, page-10135

No one here and this includes you, know the specific potency assay components.

I think I do know them - if I was you I'd assert I do know them - (because that's how you roll) because on the basis of all that I do know from the public domain - I know they had two at ODAC and what they were - I know the patent application and patent granted contents I posted about recently. Same two.

I know they have not said they solved the potency assay problem - and I know Silviu was concerned about it as recently as the start of March this year.

I know they talked of gold standards as though lesser standards in potency assay might be acceptable.

In short I am confident I do know MSBs potency assay - its two parts - its TNFR1 levels and its IL2Ralpha inhibition on co-cultured T cell levels.

And, separately, the above was just rebuttal - saying there is evidence a lot of it in the public domain though you won't see it through eyes clenched shut, I know it must remain as a weak point for two reasons - I understand the science MSB has presented and second I understand MSB has not said they have a validated potency assay or that the FDA said they did - and it would have been a huge deal if they could have said that - previously before CRL # 2 MSB had even claimed they had a validated potency assay - but that was in their opinion - then the FDA disagreed and they couldn't say that anymore.

You like Reg are in denial - he has in his sig line the bottom line is that the cells did work - the bottom line is actually that it isn't clear why the cells from just three donors worked - so its not clear that potency can be assured -so its not clear cells will work - until the potency assay is validated on the science. I'm saying on the science now not on just the FDA's opinion because I have to acknowledge its possible the FDA have slipped up on the science evaluation perhaps if the previous experts are not their or are being overruled - that is the only way I can think of that Silviu's statements about the FDA could be true. And I don't think they are true.


I could not possible care less if you think I am a smarty pants or not - I know I got the call right pre CRL #2 and how and why I did. And this is an easier call than that was - because MSB have not obtained any new data from any new patients (had they done that - they'd have said so) rather they have said the opposite - they've said the re-evaluated old data.