You would have to compare ANY 12 month open label trial to have an answer to your questions. I don't think there are many out there to compare to, to be honest. If there are please share.
To me what speaks the loudest is the money they have been able to raise at this stage. Doesn't mean the trial will work, but certainly a lot of rich folk think it will. I would prefer to have controlled data to compare to SOC but we have a very positive trend to make decisions instead. I didn't miss the boat here like a lot of folks did. I'm just trying to make an honest risk/reward opinion. Understanding why the drug MIGHT not prove as beneficial in the P3s as the open label data is a MUST in my book. I've ruled out the BS attacks. I've read through the research I can find. I've asked folks in the research field. The open label aspect of the trial is one variable on my list.