As “Breakthrough Therapy” Designations Rise, So Do Disclosure Questions
With FDA prohibited from disclosing information about products in development, sponsors must decide whether to announce if the agency has granted or denied a designation request. Communications are particularly challenging for small companies, for whom a denial might be a material event.
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Recent approvals of hepatitis C treatments Sovaldi, Harvoni and Viekira Pak lead agency to reconsider ‘breakthrough’-worthiness of Bristol’s daclatasvir and Merck’s doublet therapy. FDA’s willingness to rescind shows the risk sponsors face in trying to retain the designation as other competitors reach market.
FDA letter rejecting “breakthrough therapy” status for investigational melanoma treatment is released by the company in an apparent bid to rally support for the drug. The strategy had the opposite effect, however, causing Provectus’ stock to plummet and demonstrating the perils of breakthrough-related disclosures.
The Prescription Drug User Fee Act reauthorization made a number of important changes to the new drug review process and programs for stakeholder engagement with FDA. It also created a number of new investor communication challenges for sponsors.