In this video interview, Meri Beckwith, Co-CEO of Lindus Health, examines how recent developments with Complete Response Letters have shifted industry perceptions of FDA breakthrough designation—highlighting that it offers faster review timelines and investor visibility, but not a higher likelihood of final approval.
In a recent video interview with Applied Clinical Trials, Meri Beckwith, Co-CEO, Lindus Health, discussed the evolving perception of breakthrough designation amid the FDA’s recent
ACT: How has the industry’s perception of breakthrough designation evolved, and do you think it’s led some sponsors to over-prioritize speed to designation over the rigor required for final approval?
Beckwith: The industry's confidence, or perceived value of a breakthrough designation, has definitely taken a hit after the last few weeks. However, if you dig under the surface, the breakthrough designation was never about, if you receive a breakthrough designation, it doesn't mean your drug is more likely to be approved. The FDA has always been super clear about drugs with the breakthrough designation being subject to the same rigorous level of review as those without a breakthrough designation. It really is just about access to a slightly quicker decision. I think that is what it is. I also think perhaps that companies pursue it, not just because of the timeline benefits, but also because of the signaling to investors. Beyond just that shortened review timeline, it does have a certain kind of cache, it gets your company better visibility with investors. If you're listed, it's a great news flow item to put out. I think there's a few reasons companies pursue it, but I don't think anyone really sees it as something that's more likely to make your therapy approved.
