Biotech Values

[iwfal]

ARQL -

That is a risk a clinical program should be willing to take at that juncture. If I were them, I would have done the same thing rather than running another prospective designed ph2 based on cMet biomaker. If they hadn't excluded squamous population, I wouldn't bet on them at all. Since they did, I give them a fairly good chance to succeed.

In 2010 I wouldn't have disagreed with anything you said - and, correspondingly >50% of such first-phase-3's-after-a-post-hoc-phase-2 failed. But in 2010 we didn't have a better way.

But now it is becoming apparent (Criz, MetMab, Zelboraf) that better techniques do exist to evaluate clinical trials for kinase actors. So I am judging their 2010 decisions using 2012 criteria. It isn't 'fair' but it is my money.

As for what I would do if I were them - I'd fund some heavy duty pre-clinical work to finish in a few months to evaluate MET expression vs previous lines of chemo, MET expression vs KM curve in their ph ii, ... . And update my predict of the chance of success of MARQUEE. And if it looked poor (i.e. either outright failure or lousy HR) I start a new MET trial ASAP. (Actually they should have done this in 2011 - as soon as the MetMab data became known)