From what I can understand, HGR have a very good oral drug test...

From what I can understand, HGR have a very good oral drug test before the FDA. It seems that oraline works very well and HGR have a strong case. It seems that it's just a matter of waiting for the FDA to cross the t's and dot the i's and this should only take a few months at most.

BUT

What if it's not? Is there any chance that there is something about the oraline test that would prevent the FDA from approving it?

I'm just trying to get a handle on the relevant risks at this point. I can understand the risks associated with potential sales contracts going wrong, but I don't understand enough about the FDA and the chances of them saying "no".

The upside is enormous but the downside? Probably worth it at these prices but could the FDA say "no" and on what grounds?

Spartz.