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Re: drbio45 post# 2061

Sunday, 05/02/2004 9:19:37 PM

Sunday, May 02, 2004 9:19:37 PM

Post# of 257275
>> the companies have no interest in testing to see if the drugs help people with mutant genes. the companies have no interest in testing to see if the drugs help people with mutant genes. Since the drugs are approved they would rather give it to everyone. They get more money that way. <<

You could be right with respect to Iressa –AstraZeneca may just leave the clinical work for the government.

But Tarceva is not approved yet, and hence the FDA might see an opening to require OSIP/DNA to do more work testing for the mutant EGFR. The fact that Iressa is already approved in the exact same indication gives the FDA considerable bargaining power to make these kinds of demands.


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