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biggene

06/07/11 1:24 PM

#9046 RE: BTH #9045

IMHO it is the FDA that drags its feet.
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glass_half_full

06/07/11 1:27 PM

#9047 RE: BTH #9045

My hope for the 113 trial is that it will be an extremely robust Phase I, and that the delay has been in developing the trial with FDA input so that it yields sufficient data to move to a pivotal Ph 2.

I really can't see HB rolling out some kind of 17-patient safety trial after all this time -- that would be a bit of a disaster, no?