Why so many Phase III failures?
I am more a beancounter and know or understand little about the science of drug discovery/development. Until recently, I didn't know the difference between a small and large molecule. Even when something is explained to me in layman's terms it goes over my head.
That said, I would like to hear any thoughts/opinions/theories on why the failure rate is so high on Phase III clinical trials conducted by non-major pharmas (not that major pharmas haven't had have more than their share of major disappointments too).
It seems to me that there are way too many failures on pivotal Phase III failing to meet their primary endpoints after these drug candidates produced stellar Phase II results.
Are the enrollment numbers too small on Phase II testing? Are management ethics to blame. Have we reached a point where drug discovery has picked off all the low hanging fruit and the science has gotten just too hard to figure out? Do smaller biotechs skip corners because they are limited by finances?
Does anyone know what the current stats are on Phase III testing in terms of approval rates for major pharmas versus biotechs? I've seem to recall that major pharmas have a better than 60% chance of getting approval on drugs they advance to Phase III. I don't know if that is correct or not? I'd be surprised if biotechs score more than a 10% approval rate with their Phase III results.
Sadly, it seems to me one the surest way to make consistently money with biotechs is to short all smaller biotech stocks that have a drug soon to report it's results of pivotal Phase III results.
Sorry if this is so elementary but I'm hope some of you will share your thoughts by giving me your two cents worth. Why do Phase III results fail miserably to live up to their Phase II results? Is there one major reason or a host of reasons this is true?
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