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?
If they want to succeed, they shouldn't. They rushed original Viaject formula to phase 3. Even if it were approved, it would be commercial bust due to discomfort at injection site.
Phase 1 and 2 insulin program doesn't take that long, You can finish both in a little bit over one year. Look at HALO. One of key reasons why many small biotech have lower phase 3 success rate is they rush, don't think through by taking too many chances. The odds aren't with you in the casino.