Biotech Values

[iwfal]

CSLN and the model by the hedge fund:

absurd simulations: "as shown in the 99.9% confidence intervals for median time of PFS across the entire trial in the table below"

It isn't so much that the simulation (of what the PFS must be in order to have avoided interim to date) is absurd since in fact the median blended PFS is almost certainly very high as their comparison to historicals (which they assume to be 12 mo PFS - 18 months for worst case purposes). As usual the problem is the comparison to historicals and using non-standard measurements in the trial - in this case:

a) the trial isn't using RECIST as the measure of progression - but is instead using the appearance of new tumors

b) the enrolled patients are generally healthier than in most trials - but not in a standard way (only limited number/size of mets allowed and all mets must be hepatic.)