Get your shit together! https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alkermes-inc-597260-12022019?utm_campaign=121119_PR_FDA%20issues%20warning%20letter%20for%20misbranding%20the%20drug%20Vivitrol&utm_medium=email&utm_source=Eloqua
Our gross incompetence at maintaining a good relationship with the FDA is on display once again! Click the attached link to see just one of the news articles it has inspired. https://eur02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.statnews.com%2F2019%2F12%2F11%2Ffda-blasts-alkermes-vivitrol-branding%2F&data=02%7C01%7Clee.marks%40orexo.com%7C94c0683af4084c96723708d77e8a2260%7Cc2e2c5518fbf4c22b4b3101af7212583%7C1%7C1%7C637117004060238586&sdata=WsZn5xkuB0BCqt96hdxX6vcwrk3RqSfc4ouV%2FI74Yvk%3D&reserved=0
The warning letter is bad enough, but the fact that the FDA issued a press release is what's really telling here. They almost NEVER do that. That means that we have so mismanaged our relationship with the FDA that they want to spank us in a very public way. Otherwise they could have quietly issued the warning letter as they usually do. We got this special treatment because we have pissed them off! Don't we have people who are supposed to be helping us to build relations with the Federal Government? In fact, we have an office in DC tasked with that responsibility. How did they let this happen?
The press release is because we told DAAAP in October we weren’t doing EXACTLY what it turns out we were doing. Truly stupid. If we weren’t on FDAs shitlist before, we are now. Buckle up.
Pissing off the FDA is the gift that keeps on giving! Here is just another article. We'll be seeing these ripples in the media for months to come. Maybe we can drive our stock back down to $17.00 if the board keeps the same management team around. I know Ringling Brothers is out of business but can't we find another home for this troop of clowns? https://www.policymed.com/2020/01/opdp-sends-warning-letter-to-alkermes.html
