"Do you know for sure that the potency assay was thereasonfor...

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08/10/24

14:39

Post #: 76027873
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Originally posted by stanjupiter: ↑

Eric Rose acknowledged a problem with the potency assay. Do you know for sure that the potency assay was the reason for the 2nd CRL?

The cells respond to the inflammatory milieu of the individual, which is something MSB (and the FDA) have no control over (as in ARDS trial). Around the time of the 2nd CRL, can you think of anything the FDA may have been concerned about that was beyond the control of MSB? (I'm not saying it is/was the case, only that someone might have thought it could be. The result in 51 adults and children in the EAP, however, IMO gives a strong signal that the product is performing consistently.)

Also, Dr. Krause co-authored an article which warned of the risk of original antigenic sin (published in the Washington Post). Professor Angus Dalgleish is warning about OAS and Professor Vinay Prasad appears to be too when he quotes PK in a recent article. How might OAS manifest itself in terms of immune response? The reason I ask is your comment about "any" cytokine storm and I wondered if you had a specific one in mind other than aGvHD.
(I took "cytokine storm" to mean hyperinflammatory.)

You don't think there's an effective difference between adults and children. What I've learned is that adults and children are different; children under 10 have a stronger innate immune system. (FDA's document on GvHD says they may respond differently) and my simplistic view is that could be why they can suffer from hyperinflammatory conditions such as macrophage activation syndrome (not uncommon in systemic juvenile idiopathic arthritis).

BTW Thank you for the ref to Brianne Barkers' immunology lectures; she's very clear and good at explaining things. There's been a lot of interesting discussion on the products and trials but IMO immunology is key and I'd like more about what could be going on in potential recipients.

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"Do you know for sure that the potency assay was thereasonfor the 2nd CRL?"

Now we are splitting hairs.

I can safely assume it was one of the reasons. There were a number of reasons for the 2nd CRL. All were nominated in the ODAC minutes.

I'm pretty sure it ranked highly as the reason for the 3rd CRL. Are you suggesting it was because of the font they used in the submission?

You being right with this means what, exactly?

Kudos for at least admitting that "Eric Rose acknowledged a problem with the potency assay". Others here have argued otherwise or dismissed as unimportant.

Last edited by Pledge: 08/10/24

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