I think you're right about that, but they way I've heard them discuss the drug it's intended to supplement existing therapy. Frankly I believe this is an easier course of action as if they use it as a monotherapy, it's doubtful if it will be better than the SOC, which simply means they run that expensive trial to prove what they already think, the drug should be added to what already exists.

Many of the drug trials I followed over the years failed in monotherapies and while the company had evidence it might work as a supplement other drugs, the cost of proving it was so high that the drugs were abandoned. I strongly believe that once proven safe, the FDA should permit companies to run trials with it in the protocol they choose. Sadly they often don't, but Phase 1 and 2 trials being done in various combinations are achieving far superior results to the Phase 3 done as a monotherapy. Sadly, the FDA doesn't care how much their practices cost the drug developers.

Gary