InvestorsHub Logo

Investor2014

09/23/23 5:11 PM

#432490 RE: Steady_T #432487

Again cancer indications where the risk vs. clinical benefits equation is quite different from AD and biomarkers are quite dependable surrogate endpoints.

boi568

09/23/23 5:23 PM

#432492 RE: Steady_T #432487

Thanks, Steady. I found an earlier NIH paper that states "the FDA usually requires more than one phase III trial to establish drug safety and efficacy" but didn't provide that level of detail or current information.

blu_1

09/23/23 6:07 PM

#432500 RE: Steady_T #432487

For the drugs that got approved with >1 pivotal trial, I wonder if some of those were conditionally approved after a single Ph3 trial with the condition that a confirmatory Ph4 trial be run?