If you wait for confirmation, as your words suggest you get 10 times rather than 100x because you did not want to risk losing 1x.
Thats the decision you have to make.
FDA staff changes ( holding things up by fair means and foul ) and a torrent of medical doctors angry about lives being lost due to the slow down behind the changes occurring plus busloads of patients going to clinics in Mexico because they know it works.
