I want to believe you. That we can overcome a big government agency. The reality is no matter how much we complain and show minimal results. The FDA will go back to the CD-10 and CD-12 trials and say the same thing. That we did not pass our primary end point. They will be right and we have no way of changing that. What the problem is and has always been since completion of the trials is we showed life saving ability all though in a small group. The FDA clearly stated in their letter and it’s always been their rules or guidelines that if secondary end points show significance then you can do a trial with that as your primary end point. They are doing nothing wrong in asking us to do another trial to confirm our results of the significance. They know they are right and will not move off their stance now. We have pushed as hard as we could and it has bit us in the ass.
We had hoped they would do things for us outside of the box because of the pandemic and because they did it for others. It wasn’t in the card for us and we can scream and kick and throw that tantrum but it isn’t going to change anything. We need to prove our point in the trial we plan on conducting in Brazil.
We may be able to show our trial results to other nations and it may be enough to get an EUA there but they will also ask for a confirmation trial. It all comes down to trial design and proving that Leronlimab works. Interim results may just do that for more nations like UK and Canada but some countries might possibly allow an EUA on our past results. I will be thankful if that happens. It could mean immediate revenue. Philippines is on the cusp and an update is needed today. India looks to be possibly on the same path and I am thankful for this too. Bottom line is we have no mud to throw at the FDA because they didn’t go out of their way and disregard there own rules to help us when we wanted that chance to be special. They clearly want more trial information and passing a primary end point. We can complain only of trial design and unfair protocol. There guidance clearly was not helpful and they know it. All though It was an agreed on protocol and we just didn’t think it would end up this way. Now we know what we need to do for the FDA. We will get there in the USA. We will get there with EUA’s and possible approvals around the world first. As citizens of the USA... we know that we can still access Leronlimab in EIND and right to try and our trial extension.
Our primary focus should be international now. The FDA completed trial protocol for CD-16 and CD -17 when complete and agreed on is on the back burner but moving forward as we move forward with other countries that give us immediate approvals on past trial results as we complete the new trials in Brazil and else where. We have to focus on the international market now as our primary market until Brazil trials results open other doors.
This is where we are in my opinion. Complaint about the FDA historical protocol will get us no where. We just need to move on and get our revenue where we can and keep performing the trials that will allow us more approvals here and everywhere in the world. When the company wants us to slack off and quit pushing. It is what we should do. They need to maintain a relationship with the FDA and we should not take that away from them. The path we were on has damaged us more than helped us. It has got us no where and will not if we push even harder. Common sense says we should stop and focus on other avenues and complete trials. Let’s focus on the right paths foreword and not seek revenge. It’s damage control time for Cytodyn. My hope is it hasn’t effected our international ability to seek immediate EUA’s or equivalents. Let’s hope we didn’t damage our path.
We had hoped they would do things for us outside of the box because of the pandemic and because they did it for others. It wasn’t in the card for us and we can scream and kick and throw that tantrum but it isn’t going to change anything. We need to prove our point in the trial we plan on conducting in Brazil.
We may be able to show our trial results to other nations and it may be enough to get an EUA there but they will also ask for a confirmation trial. It all comes down to trial design and proving that Leronlimab works. Interim results may just do that for more nations like UK and Canada but some countries might possibly allow an EUA on our past results. I will be thankful if that happens. It could mean immediate revenue. Philippines is on the cusp and an update is needed today. India looks to be possibly on the same path and I am thankful for this too. Bottom line is we have no mud to throw at the FDA because they didn’t go out of their way and disregard there own rules to help us when we wanted that chance to be special. They clearly want more trial information and passing a primary end point. We can complain only of trial design and unfair protocol. There guidance clearly was not helpful and they know it. All though It was an agreed on protocol and we just didn’t think it would end up this way. Now we know what we need to do for the FDA. We will get there in the USA. We will get there with EUA’s and possible approvals around the world first. As citizens of the USA... we know that we can still access Leronlimab in EIND and right to try and our trial extension.
Our primary focus should be international now. The FDA completed trial protocol for CD-16 and CD -17 when complete and agreed on is on the back burner but moving forward as we move forward with other countries that give us immediate approvals on past trial results as we complete the new trials in Brazil and else where. We have to focus on the international market now as our primary market until Brazil trials results open other doors.
This is where we are in my opinion. Complaint about the FDA historical protocol will get us no where. We just need to move on and get our revenue where we can and keep performing the trials that will allow us more approvals here and everywhere in the world. When the company wants us to slack off and quit pushing. It is what we should do. They need to maintain a relationship with the FDA and we should not take that away from them. The path we were on has damaged us more than helped us. It has got us no where and will not if we push even harder. Common sense says we should stop and focus on other avenues and complete trials. Let’s focus on the right paths foreword and not seek revenge. It’s damage control time for Cytodyn. My hope is it hasn’t effected our international ability to seek immediate EUA’s or equivalents. Let’s hope we didn’t damage our path.
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