For sure. I calculated that FDA meeting date to be 2 Nov - not...

For sure. I calculated that FDA meeting date to be 2 Nov - not sure the company has announced any actual date yet. You can expect BOT management to provide a draft of the revised instructions and labelling, to that FDA meeting, for immediate feedback. From there they will execute the HF study, then take a couple of weeks to put the resubmission together, and lodge. Hopefully that will all be done before end of January, if not sooner. Fingers crossed, FDA may even provide approval before the full 6 months timeframe allowed for the resubmission review.

2 or 3 webinars back, Howie advised that it would take only 3 weeks to mobilize the salesforce from hiring to selling. So I would expect BOT to have all of their ducks in a row and ready to go immediately upon approval - pending possibly 3-4 weeks to mobilize salesforce.