my experience says we don't want one. Upon approval, the FDA will update their website, but if it's not approved they will communicate directly with bot... and then bot will need to work out how to communicate to the market, which might require a halt.
also, with the pdufa being the 26/9 US so it will likely be the 27/9 AUS IMO.
if you have a look how the last few approvals or rejections have gone, you will see a trend - approval: neu, tlx rejection: msb, cyc
good luck everyone!
BOT - Anything but charting, page-5866
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