Although this is definitely straight off Chat GPT, its important to note that BOT are making a new drug application.
Trials are complete. It is a main administrative milestone as it is the final opportunity for the FDA to formally ask for further information required (if applicable) to finalise the submission.
I suspect we will get some minor non-critical queries, but nothing major. This essentially means the final approval is a formality and we are underway.
GLTAH
BOT - Anything but charting, page-3972
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