I would urge you (and me and everyone else) not to get so caught up in the 42 or 60 day possibility. We just don't know. It feels like it's becoming fact on this board that the FDA is looking into it. It might be true and it might not be. Here's a story about focusing on one thing and how it can derail you. It may not be the perfect corollary but forgive me for I am but a #DaytimeRespert right now.
I sold a drug called Ketek. It was developed as a next generation antibiotic to replace, or improve upon, drugs like Zithromax (the Z-Pack). The big selling point for Ketek that emerged during training was that it could overcome resistance. Which according to the numbers, was growing at alarming rates and drugs like Z-Packs were directly to blame as they were given out like candy to anyone who was sick. That's a slight exaggeration, but you could argue most people showing up sick have a virus and an antibiotic is useless but patients push for them nonetheless and a Z-Pack seemed like a relatively harmless thing to prescribe to appease patients. Hell, maybe the placebo effect would help!
So we hit the field running with our new drug and used our fancy sales aids to show the doctors how much antibiotic resistance they were seeing. How using Ketek would be a great choice in the face of such a growing concern. I mean, it was the tip of the spear in our messaging, glossies, and direction from above.
Turns out no doctor thinks they see resistance in their practice. Or at least, not to any substantial number. You see, to them they're doing a great job and we were walking in telling them that in a sense they weren't. It's also an unseen enemy. You could blame an unresolved sickness after a run of Z-Pack on a handful of things besides resistance to antibiotics. We struggled to gain market share with a product that was, by just about all accounts, a better option. This was because we hooked our wagon to resistance and ended up trying desperately to convince the doctors of something they didn't believe in to sell our product. They didn't believe so they didn't bother to prescribe.
So it could very well be that the FDA is interested in and even currently discussing data out to 42 or 60 days. But I sense this growing discussion on the board is pushing this unknown "what if" to the tip of the spear. Once there it dictates how we consider everything else and all of a sudden we're breaking from the fundamentals. That's never good.
The most likely case right now is that we finished our trial that was expected to prove our primary endpoint at 28 days. It took a good bit of time to lock the data. The FDA (and the UK and Canada) has that data and Cytodyn is in discussions with them that are expected to resolve within 2 to 3 weeks (1-2 weeks if you lump the last four days in since the PR). All signs point to efficacy within the 28 day primary endpoint or within some or all of the secondary endpoints. Thus the discussion and not a directive to run another trial or let the door hit us on the way out. Until we hear something different from NP or the FDA I think it's a fool's errand to chase down what-ifs with such veracity.
I sold a drug called Ketek. It was developed as a next generation antibiotic to replace, or improve upon, drugs like Zithromax (the Z-Pack). The big selling point for Ketek that emerged during training was that it could overcome resistance. Which according to the numbers, was growing at alarming rates and drugs like Z-Packs were directly to blame as they were given out like candy to anyone who was sick. That's a slight exaggeration, but you could argue most people showing up sick have a virus and an antibiotic is useless but patients push for them nonetheless and a Z-Pack seemed like a relatively harmless thing to prescribe to appease patients. Hell, maybe the placebo effect would help!
So we hit the field running with our new drug and used our fancy sales aids to show the doctors how much antibiotic resistance they were seeing. How using Ketek would be a great choice in the face of such a growing concern. I mean, it was the tip of the spear in our messaging, glossies, and direction from above.
Turns out no doctor thinks they see resistance in their practice. Or at least, not to any substantial number. You see, to them they're doing a great job and we were walking in telling them that in a sense they weren't. It's also an unseen enemy. You could blame an unresolved sickness after a run of Z-Pack on a handful of things besides resistance to antibiotics. We struggled to gain market share with a product that was, by just about all accounts, a better option. This was because we hooked our wagon to resistance and ended up trying desperately to convince the doctors of something they didn't believe in to sell our product. They didn't believe so they didn't bother to prescribe.
So it could very well be that the FDA is interested in and even currently discussing data out to 42 or 60 days. But I sense this growing discussion on the board is pushing this unknown "what if" to the tip of the spear. Once there it dictates how we consider everything else and all of a sudden we're breaking from the fundamentals. That's never good.
The most likely case right now is that we finished our trial that was expected to prove our primary endpoint at 28 days. It took a good bit of time to lock the data. The FDA (and the UK and Canada) has that data and Cytodyn is in discussions with them that are expected to resolve within 2 to 3 weeks (1-2 weeks if you lump the last four days in since the PR). All signs point to efficacy within the 28 day primary endpoint or within some or all of the secondary endpoints. Thus the discussion and not a directive to run another trial or let the door hit us on the way out. Until we hear something different from NP or the FDA I think it's a fool's errand to chase down what-ifs with such veracity.
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