Provectus Tries To Put A Positive Spin On PV-10 “Breakthrough” Denial
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.
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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.
Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.
Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.