Neuro, Yes, the FDA can do whatever they please, which is what scares me :o) I hope your 70/30 estimate is right, and that the FDA doesn't have other ulterior motivations lurking about.
I'm not going to even mention the word (diversification) :o)
I expect Cortex will present data to the FDA, which will then review it and raise questions for Cortex at a formal meeting. What matters is whether Cortex can rebut the negative assumptions by presenting statistically compelling or verified data. The logical deductions you make might be valid, but are not sufficient.
This would not be the first time a company with a good product fails because its statistics, experiments or presentations are invalid.
As a pathologist I am not as comfortable with the apparent lack of changes in the frozen tissues sections as Mr. Stoll would seem to be. This process is not as sensitive as the paraffin-based histology and it is still possible that a real lesion is there. I am going to be more comfortable with negative electron microscopic findings and additional toxicology testing. I agree with your guesses about the FDA response (and I have continued to buy) but still I am a little nervous! Good luck to all.