Ayala Pharmaceuticals Inc (ADXS)

[DewDiligence]

Re: AIM2CERV

A similar 2 years of PFS data would be reasonable?

I don't think so. AIM2CERV will almost certainly take longer to read out for DFS (the primary endpoint) than IMDZ's trial will take to read out for PFS. Why? Because an entry requirement for AIM2CERV is being disease-free after surgery followed by chemo/radiation; in the IMDZ trial, patients merely need to be "stable" after surgery and chemo. In other words, the IMDZ patients will have more advanced disease, on average, than the AIM2CERV patients.

Maybe the FDA will at least grant AA to Aim2Cerv.

If AIM2CERV hits on DFS (the primary endpoint), it may warrant full FDA approval rather than merely AA. However (as mentioned above), the AIM2CERV DFS data won’t read out for a few years, and there is no shorter pathway to AA.