Many of us have been following Inhibikase and the recent suspension of trials by the FDA. Inhibikase just issued a press release regarding the concerns expressed by the FDA.
"The FDA raised several points, summarized below, in their explanation of the basis for the clinical hold:
Further evaluation of the existing safety and pharmacokinetic ("PK") data and justification supporting the use of the 200 mg dose used in the Phase 2a '201' clinical trial.
A better understanding of how the clinical trial will monitor the potential for detecting adverse events that could affect vision in trial participants and whether those adverse events are reversible.
Need for material additions to the disclosures made to investigators and patients related to the clinical and safety measures completed to date, including the potential risks to vision in trial participants."
1Trial of Bradykinesia Stem Cell Therapy Now Dosing Last Group
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