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PRINCETON, N.J., Dec. 10, 2020 /PRNewswire/
Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announced it had official discussions with the FDA on a detailed plan for a phase 1/2 clinical trial to start developing a new treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric disease, using its proprietary drug, OKN-007.
Through this FDA meeting, the Company obtained consent from the FDA on important matters, such as patient population, starting dose, approach for dose escalation, and criteria for evaluating disease response.  Importantly, there was in depth discussion on how to actively utilize existing historical patient data instead of requiring a comparative group in consideration of the nature of DIPG, a severe rare pediatric glioma and the need for all patients to receive anti-cancer treatment.  The FDA also gave detailed advice on pharmacokinetic assessment and standard of car ....

United States , New Jersey , Oblato Inc , Prnewswire Oblato Inc , Gtreebnt Co Ltd , Diffuse Intrinsic Pontine Glioma , Sarepta Therapeutics , Rare Pediatric Disease Designation , Rare Pediatric Disease Priority Review , ஒன்றுபட்டது மாநிலங்களில் , புதியது ஜெர்சி , சாறெப்டா சிகிச்சை , ரேர் குழந்தை நோய் பதவி , ரேர் குழந்தை நோய் ப்ரையாரிடீ விமர்சனம் ,