FDA of­fers pos­i­tive sig­nals for po­ten­tial pe­di­atric neu­rob­las­toma drug ahead of ODAC meet­ing

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee to­mor­row will re­view US WorldMeds’ po­ten­tial high-risk pe­di­atric neu­rob­las­toma drug to re­duce the risk of re­lapse af­ter front-line ther­a­py. USWM is seek­ing an ap­proval via an ex­ter­nal­ly con­trolled tri­al, a move not nor­mal­ly enough for a full ap­proval, but which the FDA says it may al­low be­cause of the un­met need, ac­cord­ing to brief­ing doc­u­ments re­leased Mon­day.

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