Ayala Pharmaceuticals Inc (ADXS)

[polaco3us]

SPA:
A Special Protocol Assessment (SPA) is an advanced declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval.
The purpose of a SPA is to allow a company to run or initiate a clinical trial of an experimental drug without fear that the FDA will object to the trial design itself, in the event that the company subsequently applies for product approval.

Could you pls explain what was wrong with going with a SPA in this case?
SPA is a risk mitigation instrument.

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