Cytodyn Inc (CYDY)

[gestalt2]

I'm doubtful of your timeline, I know it is easy and predictable to always go with the worst case scenario but you are ignoring some important details. Back when the protocol was agreed on with the FDA for mono, this p3 investigational trial required 300 patients, This is the minimum for a pivotal trial. It think if this was a trial that was to be investigational and require another trial to be pivotal there would not be 300 patients, there would be far less. The p2 trials are considered "learning" trials and p3 trials are called "confirming" trials. The major push for the FDA and by BP is to combine this into a learning becomes confirming trial to speed up the process. I think this p3 trial was intended to be converted and the data be used directly for the p3 pivotal BLA filing. I know you will say this is just optimism but why would there be 300 patients in an investigative trial? Why did they lower the safety requirement from 300 to 150 patients? The p2b trial has been regarded as learning and confirming by the FDA, the p3 trial is just a larger sample size to confirm the p2b. Even though the FDA has asked for 70% efficacy - this is not normal for approval. any drugs are not nearly as effective as this and are approved. The FDA wants to see what pro140 can do, not weather it works or is safe - they know this already. We have been on the pivotal trial path all along - the FDA knew it before the trial even started.


Also, It does not matter much because this will never be a revenue generating company - everything about this path is about a buy out. guessing on a timeline where the end goal is an approved drug is flawed - the only timeline that matters is where the end goal of buy out is achieved. That does not depend on the FDA nearly as much now that we have PE on mono. The world knows what pro140 is and getting it applied to the correct trial in the FDA is a technicality in my mind. MGMT must justify the value of this company with outside financial support and then the price tag is set.