Replies to post #129114 on Biotech Values

[mcbio]

It's a pretty good presentation. It showed why UFI has a place in the space:

But, given the issues with the slow washout that BIOD saw in its two most recent UFIs (105 and 107), BIOD management noted that a long washout is not an issue with the analogs. So, presumably they are hoping to just take one of the existing analogs and make it work even faster with same type of washout and hopefully good tolerability.

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

I'm not 100% sure either but I think it's just variations on one analog. And I am pretty confident it's just one analog that they are in discussions with the potential big pharma partner on, and have the MTA with, with the option available for the big pharma to partner. BIOD recently talked about lining up foreign API as well, should the talks with the big pharma partner fall through, and they would then presumably enter the clinic on their own with the potentially improved analog. (That of course would presumably be met with negativity as it would show that the big pharma partner was unwilling to pull the trigger on any deal.)

[mcbio]

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.