RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:FDA guides on how AA can be converted to full approval.The fact that the FDA's biomarker driven "one-trial" approach leads to FULL APPROVAL appears to have been lost on many here. Full approval means fully "de-risked" which is much easier to achieve particularly when this final "one-trial" is comprised of biomarker defined cohort of patients.
As the FDA has stated:
"In cases wherein historical trials did not specifically evaluate the response rate for the standard of care treatment in a biomarker-selected population of interest (i.e., available therapy is approved for an all-comer population), assessing the new drug compared to the available therapy in the same trial provides a more accurate representation of the efficacy and safety of standard of care in the biomarker-defined cohort of patients"
"This “one-trial” approach maintains efficiency in drug development and can provide early access to a drug using the accelerated approval pathway, while ensuring that a postmarketing trial is fully accrued and well underwayto verify longer term benefit in a timely fashion."