Biotech Values

[iwfal]

ONTY -

The earlier article was a little more balanced, as it did point out that median survival in the control arm may be longer than 20 months, which is one of the assumptions used when Merck designed the trial

I will strongly disagree with this - at least on the topic of what-are-the-implications-of-trial-taking-a-long-time. Martin did his assumption homework much much better than the previous SA author. He provided cites to similar patient populations I missed when I last looked in 2009:


http://jco.ascopubs.org/content/26/15/2450.short

Median somewhere between 23 and 35 months for a somewhat sicker population (because it took all comers for stage iii)


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http://journals.lww.com/jto/Abstract/2011/05000/Phase_II_Study_of_Pemetrexed_and_Cisplatin,_with.13.aspx

Median survival around 34 months - but the trial needs to be adjusted for differences in protocol between it and START. Subtract a few months for being at an earlier start point (i.e. start time for START is after induction therapy). Add a few months for not including only patients responsive to chemo/rad.


...

The point is that he makes his case that the 20 months talked about by the company and the previous SA articles is, at the very least, very very questionable. (Note: back when I first looked at ONTY I too found a lot of data about stage iii patients of roughly comparable protocol and found longer than expected survival times - but Martin has a better list than I did. Good for him - too many analysts don't do their homework. He should be able to do a better job since he should be able to put more time/dollars into it.)

PS I disagree with Martin on some of the science. E.g. he complains that the drug doesn't produce immune response like a traditional preventative vaccine. So what. Undoubtedly cancer control will be via different immune mechanisms than preventative anti-viral vaccines. Heck, we don't even really understand what marker is the correct marker for Provence efficacy - only what marker seems to imply manufacturing goodness.