Biotech Values

[jq1234]

What specifically are the AACE guidelines? And how meaningful is such an increase in the proportion of patients able to achieve these guidelines?

AACE guideline is complicated. Let's say 50 out of 100 patients consistently achieved the target for analog, 50% increase for analog plus PH20 makes 75 out of 100 patients consistently achieved the target. How meaningful? Statistically sigficant is very meaningfully.

Isn't this a negative outcome for HALO's insulin analog? Isn't the point behind a "better" analog being to reduce hypoglycemia incidence or event rates rather than having no meaningful difference?

These aren't phase 3 trials where you have two arms with single treatment duration 26 weeks or 52 weeks for each arm. These are two complicated 2-way crossover trials with treatment duration of 12 weeks where both lispro-PH20 and aspart-PH20 were compared to lispro. This is what important for this type of trial: "Both trials met the primary endpoint of non-inferiority of HbA1C compared to the insulin analog comparator, with superior reductions in post-prandial glucose excursions in the PH20 insulin analog arms."