"Does this seem reasonable?" NO
So this is were you conclude that only 25 had serum taken.
I think you are wrong. Those tests would have been part of the enrolment process of 001.
Why only 25 ? It's not hard to work out. Go back to CRL 1 . We had a problem with the potency assay giving false readings. Some lots were proven to be below par, yes a stuff up, a sad reality of clinical trials. Would you include those treated with a below par product that was not intended for use?
As it happens though, the (summary) chart showing effect would include all lots used in 001 good and bad and in as many patients as possible. The stuff up turned out to be how MSB has been able to show that the potency assay works showing both good and bad results, if we only had those good results we would still be trying to demonstrate a critical attribute to measure. Remember this chart was made before BLA 1. MSB did not know that the new potency assay had faults.
The next question?
Given the stuff up , is the data on the chart accurately recorded? Were some of the lot data from old assays, some from new ? No. That chart has been in more recent patient applications. SI would think it accurate. Remember how SI said that they were reverting back to the old assay. Could SI have used the old assay as well as the new assay. This would be one way to validate the processes that makes up the assay.
Does this seem reasonable?
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