So far no side effects worth discussing. You can get the flu all by yourself,and die from it these days. Adxs has the best results ever with the smallest amount of side effects in correlation. The cost of production at around 5 bucks a dose will have ample room for sweet margins.
"In particular, early dialogue and timely preparation for conditional applications could support prompt assessment and generation of the required post-authorisation data, and further efforts could target those therapeutic areas that so far have not been successful in applying this regulatory tool."
I believe we've had quite a bit of early dialogue.