Looks like they're having to re-do Phase 3 trials for their ultrafast insulin
They not only have to re-do phase III, they actually decided to restart the ultrafast insulin program from phase I, which is the right thing to do.
BIOD was the perfect study of small biotech on how to fail a winning product by rushing development timeline and cut corners. It always ends badly.
It's a long story. I don't think I can explain in detail here because it is going to take a long time. In short, they rushed original ultrafast insulin program by skipping phase II, even though efficacy was there, injection site discomfort issue was there due to formulation as well. They rushed to phase III, but Indian sites screwed up, so efficacy was fine if excluding Indian sites. They filed NDA, aka MNKD, also wanted to change to new formulation (device in MNKD case) for better injection site comfort when marketing. Of course FDA didn't buy it. If BIOD old management had admitted they made mistake, restarted the program back then, they wouldn't have lost that much time.
At least BIOD new management admitted they screwed up, promised to do everything right this time by doing step by step. They have chosen two new formulations, starting phase I first, then phase II, then phase III. To me, clinical risk is rather low if they can implementing their plan this time. So it is time/patience mostly, unlike oncology, time/patience isn't enough.
To get BIOD and HALO on ultrafast insulin, you have to understand insulin and diabetes market. I had followed NVO for years. I see the need for ultrafast insulin. It's highly likely one of the big three insulin makers (NVO, LLY, SNY) will partner with them if phase II data come out fine. BIOD used to be ahead of HALO by several years, now HALO is ahead by roughly one year.
Market Data 
Markets 
AI
