Ayala Pharmaceuticals Inc (ADXS)

[jckrdu]

You're right that they're just looking to modify the data analysis plan (not the trial design) to get an earlier data readout... but that doesn't change the thoughts in my prior post.

There's still 2 separate and distinct matters that the FDA will rule on; 1) Are there any changes that need to be implemented for the existing AIM2CERV trial after the FDA gets a look at the CMC data they asked for, and 2) will the FDA grant the earlier data readout.

I see them as separate matters.

______________

"by our proposal to modify the AIM2CERV trial’s analysis plan to include, among other things, allowance for a second formal interim analysis for both safety and efficacy."