16 May 2016

A Man's Got To Know His Limitations, part the second

There are some areas of human striving where quant is mostly about manipulating other humans rather than discovering more about God's Rules, finance comes to mind. Other areas are more amenable, since they are real science involved in discovering God's Rules.

One of the areas that exists on the margin betwixt the two is drug development and clinical trials. I forget where I read it, but there's the lovely adage in the field, "pancreatic cancer is where good drug companies go to die". I made a nice unrealized cap gain on one such small cap developer, but held too long. Poof. Didn't lose any moolah, net. But I learned a painful lesson.

Today brings another victim.
Aduro's chairman, Stephen Isaacs, called the findings "unexpected" given "the divergence of these data from the results of our Phase 2a study."

That's the line betwixt finance and science. Whether as a purposeful scam, optimism, or incompetence, PII studies will show the candidate to be wonderful (see: yesterday's "60 Minutes" piece on polio virus and brain cancer), yet fail (oft times spectacularly) in PIII. Various reasons have been postulated over the years. Most focus on the patient selection process of PI/II studies, which manages to find those most amenable to the candidate. PIII trials necessarily have larger patient counts and multiple sites, the result being that the investigators have less (or no) direct control over the trial.

And, it can also be the obvious: small samples are just more tricky than large ones. In the world of drugs, failed PII studies (nearly, none that come to mind) never lead to PIII studies which succeed. Kind of a one sided bias, that. But the rhetoric, "despite this disappointing PII trial, we believe deeply in the promise of FooBar, and intend to continue on with two full PIII trials in the coming months", too often comes from the mouths of Suits. They should all change their names to Barnum.

To my mind, ignoring the data from failed/marginal PI/II trials and dumping much moolah into PIII trials is where most of the "cost" of approved drugs goes. Get rid of the waste, whose only logical reason to exist is to provide drug company Suits fat salaries, and the "cost" of drug development plummets.

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