Hey TiredandHungery I'm reading differently (maybe me being hopeful). I read it as the preclinical information was submitted and no issues or objections by the FDA.
Then the following statement is made "With no issues, objections or concerns to existing data raised and studies for the data requested now underway, these should be completed and ready for submission in the next several quarters." I take this to mean the "studies for the data requested now underway" as the commencement of phase 1 to gather said data. I don't understand why it would take several quarters to provide further information just to get to phase 1 in human trials, was this not the preclinical data already submitted and accepted??
Also below is from todays investor presentation announcement, it clearly shows SEPSIS at phase 1 which is in human trails.
Please anyone correct me if you think I'm wrong.
Ann: Update on meeting with US FDA, page-14
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