Duke s 2022-23 Presidential Award Winners to Be Honored Tuesday in Page Auditorium duke.edu - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from duke.edu Daily Mail and Mail on Sunday newspapers.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 .
ERC-USAApril 7, 2021 GMT
IRVINE, Calif., April 07, 2021 (GLOBE NEWSWIRE) ERC-USA and the University of California, Irvine (UCI), today announce that the FDA has recommended early termination of the onging Phase 2 clinical trial titled ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma in a letter dated April 2, 2021 ( https://clinicaltrials.gov/ct2/show/NCT01903330?term=Bota&draw=2&rank=3 ). The FDA further recommended that the parties pursue a randomized confirmatory Phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA).
ERC-USA
ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 (Gliovac or Sitoiganap) and Application for Registration Trial for Treatment of Glioblastoma
ERC-USA Announces FDA Recommendation for Early Termination of Phase 2 Clinical Trial of ERC1671 (Gliovac or Sitoiganap) and Application for Registration Trial for Treatment of Glioblastoma
IRVINE, Calif., April 07, 2021 (GLOBE NEWSWIRE) ERC-USA and the University of California, Irvine (UCI), today announce that the FDA has recommended early termination of the onging Phase 2 clinical trial titled ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma in a letter dated April 2, 2021 (https://clinicaltrials.gov/ct2/show/NCT01903330?term=Bota&draw=2&rank=3). The FDA further recommended that the parties pursue a randomized confirmatory Phase 3 registration trial to support a licensing application in the form of a biologics license application (BLA).