I thought that is what the pre-IND is supposed to do, ironed out all the stuff the FDA does not want to see in an IND. After the pre-IND, IPIX has been packaged the trial format the way FDA wants it.
If so, in theory, that should not be any more kinks in the IND. Am I way off on that thinking?
Clear this up for me if you can. 1. The FDA can respond prior to 30 days from an IND submission with a "go ahead" for the trial. 2. They can also respond prior to 30 days with "you need to fix this". 3. And they can choose not to respond within 30 days at all, which acts a "go ahead" response.
Are those the options?
If so, would a response as in #2 result in a new 30 day clock upon re-submission or does the clock concept get replaced with an exchange that leads to some conclusion?
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