TSXV:CLAS.H - Post by User
Post by
indaknownewfieon Mar 01, 2021 7:16am
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Post# 32683626
Get approval for CILI then COVID
Get approval for CILI then COVID From a Kalytera news release not long before the halt...foreshadowing. if it get approved for one indication it can get fast tracked for the other. CILI isxa large market too.
"Kalytera plans to submit an Investigational New Drug Application (IND) to the Australian Therapeutic Goods Administration (TGA) and the U.S Food and Drug Authority (FDA) for a Phase 1 clinical study of R-107 in healthy middle-aged volunteers in order to establish that the drug is safe and well tolerated. This study is intended as a prelude to a definitive large animal investigation to prove the safety and efficacy of R-107 in a clinically relevant model of CILI.
Phase 2 and Phase 3 human clinical studies of R-107 will not be required for FDA approval for treatment of CILI under the FDA’s “Animal Rule” (21 CFR Part 314.600) that allows a drug to be registered without such studies if it is not ethical or feasible to test its efficacy in humans. Testing R-107 for clinical efficacy in CILI will not be possible because it is not feasible to evaluate the drug’s effectiveness in patients exposed to potentially fatal levels of chlorine gas. Instead, FDA approval for CILI will be based on a demonstration of safety in a Phase 1 study in human volunteers, and two efficacy studies of R-107 in the treatment of CILI in sheep. The in vivo portion of the first study in sheep has been completed, with positive survival data.