Ayala Pharmaceuticals Inc (ADXS)

[mypekeispooped]

Appears the can get the conditional approval renewed, yearly, for a total of five years. The vaccine has already extended OS by more than double. Not sure how much more effectiveness they would have to show, probably just continued safety.

"The drug company has up to five years, if FDA grants all four annual renewals, to complete the effectiveness requirement and get the drug fully approved. If the company does not do so, the conditional approval automatically expires five years after the date of the initial conditional approval. If this happens, the drug company must stop marketing the drug because FDA now considers it to be unapproved."