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Replies to #94999 on Biotech Values

ghmm

04/30/10 9:34 AM

#95001 RE: genisi #94999

BMRN:

They also talked about running at least one additional study (didn't catch if they said others). It would be in children under age 5 if they get FDA approval to do so. It wouldn't be a registration study more of a label expansion strategy. With so many patients I thought while it may cost more if they ran a second study measuring growth rate then if something happens in the shorter study (I think 24 weeks is what they said) then they still have the other study as a fallback option.