Legitimate question but in my view there are so many holes to poke with Heron's recently announced phase 3 data; of course the notoriously shady leadership team at Heron doesn't want to make the full story widely known by docs and certainly by its investors. First, look at the efficacy curves; they barely separate after 24 hours. Heron doesn't want to tell anyone the p-values of how '011 performed on efficacy for specifically the 24-48 hour and 48-72 hour time periods. By just eye-balling the curves, its clear they didn't hit statistical significance. I understand that Exparel has shown mixed results for relative pain control after 24 hours, but i don't look at the '011 data and say "oh the efficacy looks better than Exparel" and thus conclude that '011 can take significant market share shortly after it launches (if approved). Second, there are so many sneaky inconsistencies with these trial designs. Why were the surgeons in the study not blinded? This could be something the FDA picks at when they review the regulatory application. Also, the pain score ratings were administered by a healthcare professional, unlike many other Exparel studies that allowed patients to rate their own pain from 24-72 hours (after all, pain is a subjective measure). Who knows, maybe that's not a big deal, but its an inconsistency nonetheless. Lastly, there are some safety results that I think are hard to simply gloss over, such as slightly higher impaired wound healing for '011 relative to the controls. Also, the incidence rates of bradycardia were somewhat eye opening. Even though there wasn't an imbalance in the bradycardia rates in the '011 arm relative to placebo and active control, the absolute levels of the incidence rates are multiples higher than seen in other post-op pain studies, and even the '011 phase 2b studies. This is something management still hasn't yet fully explained. So I think Heron has a ways to go in the clinic to show that '011 is a superior product to Exparel. If '011 simply looks "as good" as Exparel in the clinic, as opposed to clearly superior, I think Heron is going to have a hard time getting market share in the early days of the launch given how difficult it can be to sell products into the hospital setting (ie getting in front of, and by, P&T committees, securing a J-code, training docs to use the product correctly to get good outcomes, etc). These are the challenges Pacira has navigated through (both successfully and unsuccessfully) after almost seven years on the market. Heron, with a "me-too" product isn't just going to waltz into this challenging market and find instant success. If the next batch of '011 clinical data starts to paint the picture of a superior product to Exparel, I think maybe Heron has a shot of gaining share in the early days. But the results they released a few days ago doesn't convince me -- just too many unanswered questions as it relates to the data, in my view.
