Investors Like “Breakthrough” Therapies, But Real Test Still To Come
FDA confidence to devote time and resources for a breakthrough product resonates with investors and analysts, but the real program value in terms of product sales is yet to be seen. Sponsors also must be careful to manage investor expectations once the breakthrough designation is secured.
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Breakthrough In Two Pages: FDA Offers Preliminary Advice
Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
PDUFA Negotiations: Early Communications, Breakthrough Still On Docket
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.
PDUFA VI: Breakthrough Issues Among FDA Priorities
Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.