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Re: jq1234 post# 129114

Wednesday, 10/26/2011 12:39:56 AM

Wednesday, October 26, 2011 12:39:56 AM

Post# of 257269

I am not sure if the 3 candidates (BIOD-2AA BIOD-2FF BIOD-2HH) are variations from one analog or 3 different analogs.

I went back and listened to this presentation again and I think it's clear BIOD was referring to one specific analog here, not 3.

Separately, what are the chances that BIOD could proceed directly into a Phase 3 trial with their improved analog under the 505(b)(2) pathway since they would essentially be trying to improve an already approved analog? In my notes I posted in #msg-67473029, I noted that the CEO made reference to comparing their best analog to Humalog in a Phase 3 trial should they not find a partner. I thought he was referring to ultimately doing such a trial, after conducting Phase 1 and Phase 2, but perhaps he was actually referring to consideration of proceeding directly into Phase 3.

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