Pete, As long as IPIX is the only source of supply, yes they would have to approve participation in the trial. If the trial is for some other established or very promising drug, I have to imagine they would approve.

If the combo is with some scatty drug or one which has already had trial failures, Leo might say no.

EDIT: Oddly enough, another company can apply to patent the combination of B or K or P with one or more other drugs without obvious IPIX approval. I recall that happening in the past. Perhaps Sox can put his finger on an example.