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Re: jb_118 post# 772

Sunday, 10/07/2007 5:11:07 PM

Sunday, October 07, 2007 5:11:07 PM

Post# of 9809
<<<<<"the FDA requested that DOR review its existing clinical data from both its randomized, double-blind, placebo-controlled trials and highlight pertinent additional data that could provide a more comprehensive picture of orBec®'s clinical effect">>>>


Thinking again, you could look at this a few ways.

Would it have been possible for the FDA to approve orBec last July, following the ODAC no-vote and also the DNDN decision ? If not, then you kick down-field for time.

Also, the fact that the FDA said, as early as June 13th : "give us some data, any data" sounds as if they wanted to stall, and were not stuck on any one issue.

"....on the biotech battle-field, you need some élan...."

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