Replies to post #5676 on Enanta Pharmaceuticals Inc (ENTA)

[floblu14]

Dew - is this correct? If so, you might be wrong -

Has an accelerated approval for a viral disease been granted?

Yes, accelerated approval for viral diseases has happened, most notably for treatments for HIV/AIDS. In fact, the U.S. Food and Drug Administration (FDA) created the accelerated approval pathway in 1992 specifically in response to the HIV/AIDS epidemic and pressure from patient advocates.

The FDA also used this process for antivirals and vaccines during the COVID-19 pandemic and other infectious disease outbreaks.

Accelerated approval for HIV/AIDS
During the HIV/AIDS crisis, patient activists demanded faster access to promising new therapies for a life-threatening disease with no adequate treatment options.
Instead of waiting for long-term clinical trials that measure survival, the FDA granted accelerated approval for HIV drugs based on surrogate endpoints, such as a reduction in viral load.

This approach allowed life-saving antiretroviral therapies to reach patients years earlier and led to a dramatic reduction in the U.S. HIV/AIDS death rate.