505b2 and an ANDA are different. 505b2 is common for developing a new formulation of an off patent compound, so full and large trials aren't required since the company would be referencing existing safety data.
halo would be using what's called regular human insulin, not Eli Lilly's humulinR. Regular human insulin is effectively a commodity. Personally I'd rather see halo partner with a big player and combine with an insulin analog.
I don't know why this is so confusing to you, how do you think Biodel developed Viaject so quickly? 505b2 strategy using regular human insulin.
halo would be using what's called regular human insulin, not Eli Lilly's humulinR. Regular human insulin is effectively a commodity. Personally I'd rather see halo partner with a big player and combine with an insulin analog.
I don't know why this is so confusing to you, how do you think Biodel developed Viaject so quickly? 505b2 strategy using regular human insulin.
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