1. In Vivo

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.

Analysts and investors seem to be taking FDA at its word when it comes to the promise of a breakthrough product, but those promising therapies also will have to see long-term success for the program to be validated.

There is little commercial evidence so far, and the first wave of products didn’t necessarily have the full range of...

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