I hear where you’re coming from. I simply think the FDA would get BLASTED by the public if they require a whole new trial, because at this point that decision would likely come to light in full view of influential biotech analysts and would potentially hit mainstream news. As soon as a partnership is inked, whoever covers (insert BP here) will be all over any developments with CytoDyn’s pipeline and clinical program. Especially with our nation’s chief executive bringing HIV to the public forefront recently, that might be a very bad look for the FDA.
We’ll see how it plays out. I certainly agree that IF the current trial is granted pivotal status, it would be incredibly significant. I’m betting the company knows what the answer is - dependent on hitting certain data thresholds - because it would be very material to negotiating partnership opportunities.
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