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Re: DewDiligence post# 56631

Sunday, 12/23/2007 6:18:24 PM

Sunday, December 23, 2007 6:18:24 PM

Post# of 257253
Re: MNTA

>>Generic Fragmin is clearly not a big-ticket item, but I would argue that it represents almost-free money. Hence, “reprioritized” does not necessarily mean dead, IMO.

Assume DD is right and FDA accepts MNTA's characterization capacity and ability to mfg/duplicate allowing an easy route to approval.

An additional concern would be that building/mfg/duplicating a complex mixture when done by brute force would be accomplished at a significantly higher cost than the branded. If so that would further reduce the "priority" which MNTA would accord it.

ij

There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)

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