Why $PMCB getting the IND just right is so

Quote:

AMGN erred in their choice of endpoints and the duration of follow up , which are relatively easy issues to address, together with patient selection which was also much less severe than ideal.

AMGN included in their primary endpoint items which are less modifiable by LDL-C lowering , and even on modifiable items MDCO points out that LDL-C reduction takes time to translate into outcomes benefits. This is evidenced by the longer duration of many other trials and the landmark analysis presented by AMGN showing much greater benefit following the start of year two. Beyond year one when little benefit would be expected (and was observed), there was a 33% reduction in nonfatal stroke and myocardial infarction in year two. The fact that 65% of the events in the primary endpoint which AMGN chose are nonfatal myocardial infarctions could actually resonate with payors….

…MDCO expects AMGN’s median follow up of 3.2 years to be around MDCO’s minimum. MDCO believes that nothing has come out of this trial which will turn off the FDA on approving drugs on LDL, since AMGN got what one would expect on both modifiable and non-modifiable endpoints alike. Thus MDCO believes that the LDL correlation hypothesis is well intact. Although investors will likely have mixed feelings about this, MDCO has run many successful large studies in the past so they are not deterred by doing so again in a category which they believe they can reinvigorate. Management has said that they expect to run a single Phase 3 with an interim analysis based on LDL-C, followed by an enriched enrollment focusing on high risk patients such as diabetics. MDCO believes they can benefit greatly from learning from almost 50k patients worth of data generated by others such as AMGN, PFE and SNY/REGN. Beyond trial design issues, MDCO also noted that the LDL reduction seen with Repatha diminished over time, from 61% to 54%. This is where a twice a year agent could have a major compliance/adherence advantage.