Holy chit. So you re saying ALL of the company PRs saying they expect the FDA to inspect and validate by the end of 4th quarter are what, wrong? You better re-read them. Better have them update the website. C'mon, you're making false statements.
Everyone, take one step back and then take a deep breath.
What really seems to make sense is that the company got a design approved by the FDA so that they had the initial roadmap of what they had to build. But, a design is just that, a set of drawing and plans that needs to be put into action.
Next they build it and when they are done they would want to do a pretty comprehensive in house review to see that they did it right before they invite the FDA in and ask "So, how did we do, did we build it right?"
These are word games, tthere are manufacturing standards and practices that are well documented qand if I was part of the CVM team, you can bet that I would want to do all kinds of "internal" validation before I invited the FDA in to spot some minor qlich that someone overlooked. If (and when)the FDA comes in to do the "final" validation, CVM certainly does not want them to find anything wrong.