Replies to post #20490 on Ayala Pharmaceuticals Inc (ADXS)

[$5.95akadawson-m]

So Granzer was the mediator who took AXAL to the EU commission. Also, the EU says that typically 50000 is needed for a population of anal cancer but granted AXAL nonetheless because it works in small trials

[ignatiusrielly35]

What does the last sentence in this paragraph mean?

"The sponsor has provided sufficient information to show that the medicine might be of significant benefit for patients with anal cancer because early studies show that it might improve survival in patients whose disease came back after previous standard treatment. This assumption will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status"