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Thursday, August 13, 2020 1:29:57 AM
* FDA actually approved our IND application (which allows you to test drugs in humans) in less than 48 hours. When asked to meet with them they’ve met me in less than a week when typically 60 days is the standard meeting request time.
* Worked for 4 US Presidents, worked in the FDA for the commissioner, worked in the industry for companies trying to bring drugs through the FDA, and I’ve been a professor advising the FDA so I’ve seen them from all sides.
* On our board we have a former chief Counsel of the FDA and a former Associate Commissioner of the FDA
* When that phone call does come to tell you that they have approved your drug, the FDA is even more excited then you are.
* In terms of our trials next week will be reporting data on 21 patients from Houston Methodist trial.
* Currently 86/87 patients today but once were at 102 patients next week our Independent Data Safety Board will give us their update.
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