I also read this. We know that the IND was to be submitted a while back . Does this mean it it was submitted and if they haven’t heard back in 30 days they could have started the clinical trials ? Is there some place we can see if they have started clinical trials ?
Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved.
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