RE:RE:RE:We need some confidence and action!
gv, enrollment of US patients is IMO not an issue...in fact it is likely the FDA is OK with the now revised (again a major revision which speaks to design failure) trial design but as best i know the FDA requires 2 PIII trials with confirmatory results before giving approval, particularly when there is an SoC (which i assume is either LIpitor or Crestor)...that i believe is the core problem and now is being publicly acknowledged by RVX in their last filing re. "additional trials" or whatever they reflerenced...now if 208 had truly spectacular results (like the 77% they touted before) the FDA may accept the 1 trial data and may do other stuff but going in it won't happen (unlike the chinee who may approve the product on almost no data (it being a commie country and all that) and unlike EMA who may approve on 1 trial)...i could be wrong but this is my current belief...PS re. ODD IMO RVX is best served to wait until the new US law re. drugs (just passed last week or so) to be sorted out as as best i know it includes the potential for approval based on PII trial results