It remains a mystery to me why the FDA didn't allo
Post# of 153798
(Total Views: 517)
Posted On: 04/01/2021 11:44:40 AM
It remains a mystery to me why the FDA didn't allow four doses of a drug that had been safely used on HIV patients for years, but it's pretty clear the FDA didn't understand or believe the CCR5 treatment pathway early on in the pandemic. It was all about anti-virals at that point. When you consider that phase 2 trials are normally exploratory, to determine most significant endpoints, dosing, etc., then Cytodyn definitely knocked it out of the park. Unfortunately, the rising death count from the pandemic added an urgency and gravity to the situation, and resulted in phase 2 and 3 being combined into one trial. This made if feel like an all or nothing proposition.
Imagine if the trial had proceeded as a phase 2 in the usual fashion and the results came out that we had an 82% survival benefit with only 2 doses!! Imagine if all we needed to change for phase 3 was to increase the dose to save even more lives!!! We would be ecstatic and shouting it from the rooftops. Well, that's where we are folks. So, I'm going to consider the trial for what it really was, a very, very successful phase 2.
Do we have enough to get EUA approval? Yes, I believe we do, because we've proven we are safe and potentially effective. But I am very happy that Cytodyn has opted to go into trial in other countries. We will be hedging our bets and helping people at the same time. This is a really smart move.
Big pharma controls the media here in the U.S. (every other commercial is for some drug or another, all with staggering lists of side effects) so I don't expect a ton of media coverage right now. I don't think they have as much influence in other countries, especially those with socialized medicine, so I expect our first approval/big media will come from overseas. The only question that remains for me now is will the FDA get out in front of this, or be playing catch up after another country steals our thunder (and our drug supply)?
Imagine if the trial had proceeded as a phase 2 in the usual fashion and the results came out that we had an 82% survival benefit with only 2 doses!! Imagine if all we needed to change for phase 3 was to increase the dose to save even more lives!!! We would be ecstatic and shouting it from the rooftops. Well, that's where we are folks. So, I'm going to consider the trial for what it really was, a very, very successful phase 2.
Do we have enough to get EUA approval? Yes, I believe we do, because we've proven we are safe and potentially effective. But I am very happy that Cytodyn has opted to go into trial in other countries. We will be hedging our bets and helping people at the same time. This is a really smart move.
Big pharma controls the media here in the U.S. (every other commercial is for some drug or another, all with staggering lists of side effects) so I don't expect a ton of media coverage right now. I don't think they have as much influence in other countries, especially those with socialized medicine, so I expect our first approval/big media will come from overseas. The only question that remains for me now is will the FDA get out in front of this, or be playing catch up after another country steals our thunder (and our drug supply)?
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