Antares (15) - big trouble in appletown - Antares Vision


“So let me try to answer that multiple-layered question as best I can. There’s no indication that this is some broad concern with regards to the class. As far as we know we have not had any communication with the FDA that suggests that. And so until we get in front of the FDA and until we determine what they are looking for us to do, I would not start to be concerned about those more broad applications or broad issues that you bring up. I think that our PK data was excellent and how that translates to the FDA analysis of safety is really – we don’t know what they’re thinking as far as [juggling] what their overall concern is. So I would say that we have information to suggest that’s an issue. What I stated before and I’ll say it again, we are committed to XYOSTED. We think it’s a very good product, we think it’s a much needed product in this space and we’re going to do everything we can to get this product across the goal line and get it launched. To try to answer your question, I think your question was difficult, because we haven’t been in front of the FDA, but like I said, I don’t see any move or unwillingness of the FDA at this point to approve a product like XYOSTED.”

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