OK, we'll give Leo a free pass... Wasn't data suppose to be completed End of August? So, every day there's no results pushes everything back... Without data the FDA won't give a nod... How long will that process take? LOL Wake us up in October now!!!
That's the exciting thing here. We just don't know when. I just posted the CTAP FAQs. They check multiple times per day for new applications. An upcoming holiday next week doesn't stop them from working the rest of the week.
Per the June 5th GMU announcement, the Aug 24th IPIX PR and the call I had with IPIX, we have the information necessary for an IND. I will take IPIX's 'early September' comment literally. It did not say first half of September, but rather it said early September (to me meaning sooner than later, but i can always be happy with it meaning before Sept 15th as well). I don't believe a pre-print is a requirement of CTAP so long as we have all the information necessary to inform CTAP
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