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Re: biomaven0 post# 110527

Thursday, 12/09/2010 12:22:48 AM

Thursday, December 09, 2010 12:22:48 AM

Post# of 257253

FoB's are not yet ripe in my view - need to wait for the final FDA guidance before embarking on an expensive program.

I disagree with that assessment and strongly so.

Although not fully specified, the approval pathway for FoB’s is sufficiently elucidated to enable such companies as MNTA to proceed with development without incurring undue regulatory risk. Indeed, MNTA has already told investors that it intends to advance its FoB programs with expedition.

Holding off on FoB programs in order to obtain more regulatory “clarity” would be the height of folly, IMHO.

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