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ghmm

12/19/11 7:51 PM

#133372 RE: BTH #133370

For some of the rare diseases that has been discussed (Adaptive Trial Design). I am not sure where it stands now at the FDA. BMRN's former CMO was a big proponent of that and was involved in some activism for it. Don't know if it was him or someone else who envisioned trials where you would adjust it as it goes along -- I can imagine Fleming loving that :-)