Monday, August 29, 2022 11:32:17 AM
“We had a constructive & detailed discussion with the FDA & obtained clarity on various key CMC requirements to mitigate the risk of future delays for potential Investigational New Drug (IND) and New Drug Applications (NDA),” said Marc H. Hedrick MD, President/CEO of Plus Therapeutics. “The Company remains on track, on time & on budget to have cGMP 186RNL available in the 2nd half of 2022 for all ongoing & planned ReSPECT™ clinical trials.”
Press Release: https://ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-announces-summary-fda-meeting-companys-cgmp
Recent News ($17.6M CPRIT Grant & Share Repurchase Program): https://ir.plustherapeutics.com/press-releases
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