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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-376

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JB1975

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27/03/24

18:19

Post #: 73089265
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Originally posted by Grainger: ↑

Thanks for the very fulsome reply on LN2 storage. Having written protocols for cryostorage in medical research institutes and Universities I am pretty clear on it's limitations and BTW not all are yet vapour phase. I suspect Lonza's would be however. Given that MSCs are cryopreserved I am pretty comfortable they are viable after thawing and as you acknowledged they can be stored for lengthy periods.

Lots of ifs and buts re availability of assay materials that you quite simply can have no knowledge of unless you know exactly what was used and clearly you don't

I am pretty comfortable that the principle investigator understands that her cells were from passage 5 and the ODAC materials say 'One vial from a donor cell bank is stored and further cultureexpanded for three more passages. The cells are harvested following passage 5'. Very clearly all cells given to the patients have been passaged the same number of times. Different donors possibly but if they are measured reliably and consistently as per FDA requirements then they are all good. This is what has been argued for years with the FDA to this point and it appears that they are open to the fact that MSB may well have done enough to meet this standard; at least to the point of giving the green light to submit the BLA.

Thanks for highlighting were you were sourcing the information re potency assays. I have the ODAC minutes and it is clear there what the potency assays were that were submitted to the FDA. SI has stated clearly that the potency assay was one that was not previously submitted to the FDA but was used in the trial. (he in fact said 'a new -second potency assay'; a stumble corrected referencing new) It therefore by definition not one that is referenced in the ODAC minutes. I assume therefore that you have no knowledge of the potency assay data that he has now submitted.

i will let your condescension and hubris slide through to the keeper, outside of saying you have no idea of my background, education or capability. I prefer to keep my language non technical in non technical fora. I have no need to appear smarter than I am.

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Grainger the above two screenshots are from the AM transcript of the ODAC meeting - a Dr Morrison asks Silviu a question and Silviu replies.

Please see Silviu's "We hadn't been measuring I suppose, other quality attributes or other factors."

I don't want to waste my time and I don't want to waste yours.

Do you see any conflict between what Silviu is saying there at ODAC and with his apparent position (I don't want to misrepresent you or him) - but I'm paraphrasing for convenience - that they had another potency assay they used at the time but didn't report...

Because I do see some tension there between those two things myself.

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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-376

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