Solid, realistic summary, Gfp. A couple of supplemental thoughts:
1) The absolute necessity is for the IND to have been filed. If it has not been, something has gone seriously wrong. I expect to hear that it has been filed, but this is one bottom-line must-have. I agree with you that the go-ahead for the IND (which is conveyed by an absence of response) will come in October, hopefully early in the month.
2) A non-Cortex source told me a few weeks ago that the SA trial had 18 completions. I hope to hear that the trial will be unblinded in the next 2-4 weeks, regardless of whether they end up adding an additional couple of patients. SA is a wild card whose value is not going to be significantly enhanced by adding another case or two. It's time to see if this enormous effort paid off--or not.
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