Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-598

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whytee

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27/05/24

08:57

Post #: 74018553
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Originally posted by Bazsa ↑

I presume that your problem with MSBs work on potency assays that are in the public domain is that N values would be very low. MSB had a fair go at validation of this data by looking at the expanded access protocol and previous P3 trials. Never the less the FDA did not find this data compelling enough to be assured that current stock would be equal to that used in 001 as we found out in CRL 2.

So what has changed that led the FDA to conclude that the clinical data is now sufficient for refilling.
First we have seen changes in the FDA. The way they now assess data has changed. Could it be that data that was dismissed last time as anecdotal is now considered as real world evidence. This could mean that the validation process that MSB used is now excepted. We also know that there has been a lot more work on the potency assays. Not by any means insignificant is new clinical data that would have been generated post CRL 1 and 2. We know of the 70 plus adults, how many children? N values would have increased substantially, could have added 10 more batches treating say 7 adults and 3 children.

Of course speculation on my part, we don't know, so perhaps move on. How good are those CYP announcements? Marking comparison with Reach 2 controls and worse they actually tried to get investors to look at a control in a group that was refractory to Rux.
Your call
"this does look like a good announcement."

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That's all very well. But has SI yet completed discussions with th FDA over the specifics of the labeling? I really want to know because according to posters here a year ago, those discusions were well advanced?

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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-598

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Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-598

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