Re: Important and worthwhile read: FDA definitions on Class 1 vs Class 2 resubmission
biolurker, I certainly wasn't trying to question your knowledge about FDA requirements. My statement about looking at the FDA statement on remote inspections was directed to the board and related to my thoughts about a physical inspection.
I sure hope you are right about Class 1. However, saying that, without any support why you think that way, doesn't mean much. For example, I could say fmrick is a great biotech trader. That doesn't mean much or convince anyone. However, if I list all his trades the past year and great gains he has made, then people will actually understand and believe it. In all seriousness and certainly not intended to offend, why do you think it will be a Class 1 based on your knowledge of FDA requirements? Class 1 or Class 2 is a big issue for all of us holders so if you have any detailed insight on why you think it will be class 1, I'd appreciate your thoughts (and I think others here would too).