Ayala Pharmaceuticals Inc (ADXS)

[jckrdu]

"What does earlier data analysis have to do with the functional aspects of a trial? Why would the FDA even start looking at the functional trial design? That’s what I’m missing."
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Good question, and I'm sure ADXS was surprised as well when they were notified by the FDA. KB spoke to it a little bit when he said in the PR that the FDA's actions (partial hold) was "prompted" by ADXS' request for an earlier data readout. That sentence seems to imply that KB was not expecting that kind of response and information request from the FDA.

It seems that when the FDA started reviewing ADXS' request for the earlier data readout, they simply came upon something that didn't add up... and asked ADXS some questions. Those questions are material enough from the FDA's perspective that they don't want new patients enrolled until the questions are answered.