banter and General Discussion, page-4682

Regardless of how compelling our potency assays are questions will always be there

Those questions I asked in post 63682511 are specific not general. You don't have to know the answers its a free world. But the questions are still relevant.

That it is possible to measure potency in other ways has been acknowledged by amongst other people Silviu Itescu at ODAC.

You are basically saying that because you can not be sure, die.

No, I'm not. That's a complete mischaracterisation. I'm asking relevant questions based on reading relevant material. And I'm giving specific sources.

We have addressed the doubt raised by the FDA on potency assays in at least two way.
1st and most importantly which has been pointed out many times and you continually ignore is that the reason to insure batch to batch consistency has largely been removed as a response that is linked to long term survival in patients that have no better than a 20% chance of survival can be measured with in the first few days.

Are you talking about findings reported in Kasikis et al 2021 or something else? If you're off on some tangent with results from other material I need at least a reference to know where you've gone. I certainly can't agree that the reason to ensure batch to batch consistency has been removed.

The only cells that went into GVHD001 patients came from just 3 donors. Those donations were made prior to 2010 (sometime in 2009 at the latest). They seem to have only been release tested against TNFR1 expression and IL2Ralpha inhibition in co-cultured T cells not tested for other possible causes of potency - like for instance interferon gamma processing - which MSBs own slide in the post above CC-22, shows doesn't overlap with the TNFalpha NFkappaB pathway its separate to it. What is IDO doing on that slide? So its not unreasonable to ask how can you (anyone) can be sure that it wasn't the cells capaciity to handle interferon gamma rather than TNFR1 expression that wasn't the thing that made them potent in the three donations from back in 2009 that eventually found themselves in all your results.

These are not wild and whacky questions I'm asking - they go directly to whether the potency assay is good enough to ensure potent product will be made from future donations that make up donor cell banks.

Its no answer to just say here's a question in response to your question and its no dispatching of the matter to simply mischaracterise what I'm asking as something else as though what I'm asking is irrelevant when it clearly isn't.

If you can't answer you can't answer. But please don't mischaracterise me as saying die when I'm asking relevant questions.