30 days from the week of Sept 9th would be Oct 8th plus a couple of days, and it's now the 4th. I suspect they heard back from the FDA and that is why they moved forward with engaging Syneos as the CRO at this time.

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On Sept. 9th Dr. Jay said the protocol for CRC was being submitted that week. (It was what he called "the final protocol." I believe the FDA has 30 days to respond. That would put their response to the CRC protocol on or before the 13th of this month. An approved protocol for a marketable indication would be worth lots of cheering, at the very least.

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