key issue IMO for the FDA...what is the LONG TERM impact of 208??
..so we have RVX pumping 208 based on what 26 week data, and then they come up with a PIII trial designed to take over SoC mark from crestor and now it seems lipitor based on MACE data...so the smarty pants FDA likely says yeah we get it but what is the impact of 208+ over say a 2 year period will MACE be better, worser or the same as the SoC and what of the other QoL impacts???and so the FDA asks RVX to hand over the long-term data of RVX and RVX is empty-handed and the FDA says well as you have none of this data we require 2 LONG-TERM PIII trials...i betcha this is quite close to the dialogue and remember i believe RVX was once just touting MACE ASAP trial...
..PS the rubes would do well to study FDA protocals, etc., it makes coming to sensible conclustions much easier...
...PPPS and think of GV he should never be recommended 208+ in place of crestor unless his doc knew it was good for years and years and years and
...and lastly whatever happened to that ODD pump IMO share price of RVX would not be cratering had DM come through with that pumped up supposed thingy..90 days folks application to decision...hmmmmm, did they apply and get rejected??? or was it all pump and circumstance???