Not sure what cost benefit analysis you are referring to in your...

Not sure what cost benefit analysis you are referring to in your post. There was prior reference to safe acne drug but Safety can really only be assessed in the presence of efficacy, FDA uses a benefit risk analysis when reviewing new medications. The question at hand will be if they buy-in to story about Phase 2 efficacy, agree company has the manufacturing process well controlled and therefore allow for Phase 3 to proceed. If they have concerns or doubts they could require added investigations (human and animal) before allowing Phase 3 or they could share that it is the company’s risk to proceed and benefit risk would be considered a review issue if and when NDA would be submitted. This will be written in the meeting minutes and part of company continuous disclosure requirements.
Milestone meetings like the End of Phase 2 are Regulatory defined events offered to all IND holders, having the meeting granted is not in and of itself meaningful but rather the outcome and minutes of the completed meeting is the meaningful outcome. FDA is required to schedule the meeting in accordance with their Regulations, Type B meeting which this is should have been offered within 60 days of the meeting request. Since the Company has been touting this meeting since the Acne study reported in October so we should require some concrete information before the Annual meeting vote.