Been in the industry 25+ years. There is no chance BIOD shelves 123 at this point. Not unless they want a drawer full of lawsuits and permanent loss of industry reputation for all all involved.
The highest hurdle has been jumped, and the drug never would have gotten to phase 2 based on your assessment of FDA process.
No improvement over Humalog? Weird statement on about three different fronts, starting with the fact that BIOD-123 is not in the same class of therapy as Humalog. It is next generation, ultra fast acting.
1. It is an improvement over Huamalog by definition, because it's a FAST-ACTING insulin.
2. The demonstrated non-inferiority, proven with P2, pertains to CHANGE FROM BASELINE HbA1c.
3. One of the proposed targets for the new product (lower admnistration site pain) was compromised by (minimal) higher incidence.
That demonstrates your poor understanding of the FDA.
The FDA's decision on whether or not to allow a new drug come to market is not based on superiority.
If this was the case then there would be no aphidra on the market since humalog already existed.
Non-inferiority and safety are the key steps. FDA will let the market decide whether or not the drug will be successful.
The secondary endpoints are key.
I'd like to see the CGM data on decreased postprandial glucose excursion as well as the real breakdown of hypoglycemic events.
These will be good endpoints to meet...they will make BIOD 123 a marketable and SUCESSFUL new insulin.
big difference between the two,remember biod 123 is a rapid acting insulin,while humalog is not,kinda like apples,and oranges. if you don't get it,hey what can one say,i will say this,there's one big bargain in danbury connecticut though !!!!!!