Ayala Pharmaceuticals Inc (ADXS)

[ubmmg]

Nothing wrong with the SPA except for the cash needed to complete the trial increased significantly. (1) They paused to get the SPA approved, and took for over a year. (2) Adjuvant setting trial doubled the length of Phase 3 trial.
Trial size is close to 450 patients, and it would definitely provide good p-value. The trial estimated to finish in 2021. Should they decided to go with Ph3 as a continuation of Ph2 with N=200 or so, they would have likely gotten acceptable p-value (it's a sin to run a placebo group for those poor women!) and be done early 2019. We could have been anticipating Ph3 readouts this time around. That's the difference.
There could have been other ways to set up this Aim2Cerv trial (partnered) to make these both trials work. DOC was not creative in this regard, he was creative enriching himself.