banter and General Discussion, page-10162

I think this is spot on. SI has previously claimed that they had a "validated" potency assay, Dr Rose then said the potency assay had problems so they had "reverted" to the previous assay and the validated claim disappeared after the last CRL. The truth is that the claims around the assay haven't been validated by any new data that could only come from a properly designed and conducted trial which the company has steadfastly avoided. Instead they have substituted data mining and manipulation of the deficient data they already had to try and make some kind of hypothesis as to how it's supposed to support their position. The FDA didn't buy it last time and quite rightly.