Over a period of 20+ years I have dealt directly with many German/Dutch/Swedish/French/English/Irish/Japanese/Chinese management people usually near the top of their organizations. No two are the same and none are like American in terms of style and how information/facts/truth might be available or used. Most of this experience has been dealing with regulatory matters of compliance(or else) w/21CFR part 820-210-211, often w/consent decree follow up or 3rd party compliance.
All cultures have their own manner and style. Most are very private and guarded. Americans tend to project their beliefs and think that when we are told some relevant fact w/supporting data it must be true (just like US where people typically want to be trusted). We think in US that if you cannot trust someone you will not do business with them. Other cultures do not see the world at all like Americans do and seemingly feel absolutely no reason to play by other rules than in-country daily practices. Typically, other cultures process the crap out of information(endless meeting/discussion) and do not make any final choice, there and then. Anyways there are huge gaps in how we all get things done. American culture does not apply universally and that also goes for playing by FDA rules. Even when rules are written and agreed to with handshakes all around, means nothing unless you verify continuously.
The other point worth knowing after all this is that... "German managers typically do NOT DO HELP". DR.M. is doing his best to play by FDA rules I am certain. Beware we have no real idea what his management version of compliance REALLY is. Our calibration could be way off. This fact may partially explain some of what we experience as shareholders. We will find out when it happens or soon before. I am not being critical just calling it as it is. He knows we are not stupid and will keep the ball in play. We must work hard to not get too far in front of these processes. He could pull one in any day, IMO. Doing a thing different from what was planed is not seen universally as a big deal.
