Does anybody know if an individual or group at MNKD has been appointed as an "Oversight Manager/Team" ?

It seems like it might be a good idea if they have not, lol. A person/team in charge of KNOWING the ENTIRE regulatory procedure for submission. A person/team in charge of making sure that small, seemingly insignificant requirements do not go unnoticed until pointed out to the FDA staff by a hedge fund manager ?

A "regulatory compliance" officer/team if you will. Someone that points out the "i" 's that still need dotting and the "t" 's that still need crossing ? For example : What is the timeframe required to request WHATEVER factory inspections that will have to be approved prior to FDA approval ?

Are the previous inspections still valid or do they have to be updated ? Can they be requested in advance so as not to further delay the start of manufacturing/production ?

Are there any more obscure rules, paragraphs or provisions such as "human trials for any new device" - that need to be addressed ? Do we need to hire that Shrekeli (whatever ! ) hedge fund dude as a consultant to point out to us what else we have failed to find in the regulatory approval process ? Im hoping that with all the extra time that we have had, there will be NO FURTHER surprises from MNKD on the compliance issue for/from the FDA !

Sincerely praying for approval this time around. We are LONG overdue ! GO MNKD !