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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Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.
Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.