Food and Drug Administration website. ... The principal aim of the pre-IND meeting is to ensure that the drug development plan and future clinical trials are going to be acceptable to the FDA. This is an opportunity for sponsors to gain valuable feedback from leaders in the industry.
In the CC, does the CEO essentially state that although a quick clinical trail, one is needed which takes about 28 days? So no direct approval, no immediate approval to sell the drug in US. Article imo is misleading.
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