MSB (ASX) banter and General Discussion

Originally posted by JB1975 ↑

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.

Expand

I think this is spot on. SI has previously claimed that they had a "validated" potency assay, Dr Rose then said the potency assay had problems so they had "reverted" to the previous assay and the validated claim disappeared after the last CRL. The truth is that the claims around the assay haven't been validated by any new data that could only come from a properly designed and conducted trial which the company has steadfastly avoided. Instead they have substituted data mining and manipulation of the deficient data they already had to try and make some kind of hypothesis as to how it's supposed to support their position. The FDA didn't buy it last time and quite rightly.

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