I’ve read it two ways. The FDA has to send the company back a receipt of IND app letter and the 30 days begins, or if no response, then begin trials after 30 days. The first seems more logical. Hopefully the FDA checks their mail often! Also the FDA can send back a reply early with a go ahead. (Why has this not happened)? To me it’s definitely a material event if we received a response from the FDA of changes to the application, and therefore another delay. I say every day after the 20th, up to the 30th hits the deadline that lines up with the submission of the IND.
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