Replies to post #67092 on Ayala Pharmaceuticals Inc (ADXS)

[hovacre]

So... A field study was required to gain conditional approval and a further field study is now required to move from a conditional license with 24 sites to full licensure. Requiring an indeterminate number of field studies is obviously the USDA’s way of slow walking full approval so they can delay making a decision or taking a position for as long as possible. Bureaucrats doing what bureaucrats do best.

This wasn't an arbitrary decision by a bureaucrat. It's a pretty standard procedure with the regulators. You get a conditional approval based on relatively few data, and in exchange you have to demonstrate that the tech is feasible, safe, and effective in a confirmatory study.

It's the same with the FDA's accelerated approval and the EMA's conditional approval.