Ann: Paradigm Receives $7.36m R&D Tax Incentive Refund, page-43

Can't see 2x2 being a problem in the slightest. Never have. Sponsors - by and large - design trials. The burden of proof on efficacy and safety is on the sponsor. They take on the risk if their dosage subsequently shows AEs in trial. The agencies will work with the sponsor of course, and will certainly step in if a dosage is likely to be unsafe - but it would be mindblowing if they did so for 2x2 in my opinion. The dose has an extraordinarily strong safety record. There's been nary an AE in humans for iPPS 2x2, save bruising around the injection site from the repeated subq injections. Afraid I don't believe there is a great deal of concern re: 2x2 green light reflected in the current SP.