Ayala Pharmaceuticals Inc (ADXS)

[DewDiligence]

We should be going for [FDA accelerated approval] as much as possible

The unmet medical need in second-line cervical cancer opens the door for a single-arm trial based on ORR, as evidenced by the excerpt of the PR I posted in #msg-135285471. However, the FDA are not pushovers and you have to show them a legitimate dataset—the SGEN/Genmab trial in the PR I posted will have approximately 100 patients.

If ADXS had conducted a similar-sized trial in second-line cervical cancer and had generated a decent response rate, there would have been a case for FDA accelerated approval. Another missed opportunity.