I have read most of the comments here and come to a few conclusions.
1. FDA cannot release the results of the PDUFA ( good or bad ), before Mesoblast does due to listing rules.
2. MSB might have pre-emptively halted with the expectation FDA will announce on the second, which they might not have.
3. MSB might already know the decision is approval.
4. MSB might already know the decision is "not yet".
5. MSB might have initiated recruiting in the CLBP trial.
3 and 4 are mutually exclusive and cannot co-exist in this version of the multiverse.
If 4 has occurred, it's possible 5 is being organised to occur, as was the case with the previous CRL issuement. Good news / bad news
https://www.fda.gov/files/vaccines,%20blood%20%26%20biologics/published/Final-Guidance-for-Industry--Potency-Tests-for-Cellular-and-Gene-Therapy-Products.pdf
Potency is defined as “the specific ability or capacity of the product, as indicated by
appropriate laboratory tests or by adequately controlled clinical data obtained through the
administration of the product in the manner intended,
to effect a given result.”
Regulations require that “[t]ests for
potency shall consist of either in vitro or in vivo tests, or both, which have been specifically
designed for each product so as to indicate its potency in a manner adequate to satisfy the
interpretation of potency given by the definition in § 600.3(s) of this chapter.”
Ideally, the potency assay will represent the product's mechanism of action (i.e.,
relevant therapeutic activity or intended biological effect). However, many CGT
products have complex (e.g., rely on multiple biological activities) and/or not fully
characterized mechanisms of action (MOA), making it difficult to determine which
product attributes are most relevant to measuring potency. Nonetheless, all attempts
should be made to develop potency measurements that reflect the product’s relevant
biological properties
Now it was already stated from MSB, that the level in INF Gamma did not reduce in the presence of Remstsmcel-L, however the biological activity of the cells is scientifically ( P value less than -.05 ) in multiple different test groups, and the entire group linked to survival.
This means... INF gamma would not be a good measure of potency, since MSB's data shows INF Gamma has no relationship with survival. Therefore, why use it.
IL2 R alpha on the other hand has a very tight relationship with survival, in all categories, in all treated parients, but particularly with the hight MAP patients where it appears to be most effective - therefore IL2Raplha supression in Vitro is linked tightly to a given result.... survival.
(20min delay)