$PLX Patient after patient on Unigal talk about how amazing it has been and virtually all of them (I’m not kidding) never want to go back to their prior treatment. The pharma kinetics are outstanding The P1/P2 results were outstanding The P3 Bridge results were outstanding The P3 Bright results were outstanding So, why would we expect any different from upcoming BALANCE data? They will be outstanding and the FDA will have absolutely NO choice but to allow this Fabry treatment to enter the market. Anything else is criminal - and not only investors, but the Fabry community itself should be up in arms at the FDA for dragging their feet. These people are SICK and SUFFERING
@Cash_Flow BALANCE is different from other trials with a much harder to hit primary endpoint going head to head with fabrazyme in a heterogenous pts pop with lots of pot confounders that impact eGFR slope diff. THAT is why...😏
@elmono @Cash_Flow there’s 25 years of GBL3, Mainz severity, eGFR from Fabrazyme and placebo.... why is it harder. BRIDGE was ran against Replagal and Replagal numbers are a touch better than Fabrazyme, eg, Balance should’ve equally as well (if not better). They got 2 year data from 11 patients in Balance extensions.... Mainz severity approved 40% over those on Fabrazyme!!!
1 Like