I can’t believe I am again going to disagree wit
Post# of 148298
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Posted On: 05/22/2021 7:36:57 PM
I can’t believe I am again going to disagree with you.
The FDA may of screwed us on the HIV BLA but did they really or is that just a perception? My understanding from you on a previous post of yours was that we were delayed because we offered a RO test to help understand our MOA that they didn’t quite understand. Then you said they made us grab more trial information concerning RO in our trial to try to understand. Therefore extending our trial unnecessarily because it wasn’t in the trial pre-protocol. It was added after... that is what I understand. So it really falls on us that we offered a test to help validate our position for our BLA and they the FDA agreed with us and asked us to verify the history of the testing and put it back on us to extend the length of the trial with this testing since we brought it forward. Well, we screwed ourself it seems. The FDA only accepted what we were trying to show them results for and then we accepted the new protocol. Problem was that it wasn’t really what the FDA wanted when all said and done and the RO testing became the problem. Wasn’t proper for whatever reason. It didn’t meet the grade of proper testing for whatever reason. Now you can correct me if I am wrong on these perceptions and I will gladly accept any and all criticism. I believe I am only repeating what you have said and I have learned on this board.
As for the CD-12... we had results recently that look really good but are on a small group or subset of critical patients that is only 62 people of the 384 people in the trial. Now I wish with all my heart that that was enough for a EUA but as we know now it is not enough and it’s not in the FDA guidelines to give an EUA on anything but a primary endpoint. We now also know that we didn’t meet as a whole on the trial any endpoints primary or other. We also know that others didn’t meet end points but got an EUA. It could be very well our pushing that has already cost us that EUA. We will never know that. One thing we can surmise is that it didn’t help us being pushy with the FDA or maybe we would have the EUA. So we essentially struck out and yet we believe we should continue to push when we are sitting in a lose/lose situation? How can we use our judgement better? My belief is we let things settle and see where everything settles out to. Still keep our relationship and trials going to fall back on. We have to because that is where we have to perform to get any future approvals.
My opinion is we pushed already and it cost us respect and better judgment on a possible EUA. Because we know it didn’t get us an EUA. Added pressure could very well spread our relationship with the FDA even further apart. That to me is the worst case scenario and is something we can cure if we just stopped on our assault of slamming the FDA. Now I know opinions differ and we are all entitled to our opinions. My opinion of stopping the pushing and letting things settle is just what I believe is the best case for us as a company to keep what little relationship we might have left. I think it is ultra important to have a great relationship with the regulators. I am a people person and have negotiated contracts in a groups atmosphere and have a good understanding of personal grudges and how they affect negotiations. I personally never push to get my way but strive to show my position and make everyone understand why my position is my position or just the opposite in asking someone to explain their position to me like I am a 4 year old and just don’t understand. Being understanding of everyone’s position is the best place to be in an amicable agreement or a way to achieve that agreement. It’s alway give and take when negotiating and you never get everything you want. But start high and settle in the middle. That’s my best advice. We have pushed hard and high and we need to settle down and see what will become of our future and what mending we will have to do in order to acquire approvals for the indications of Leronlimab in the future.
The FDA may of screwed us on the HIV BLA but did they really or is that just a perception? My understanding from you on a previous post of yours was that we were delayed because we offered a RO test to help understand our MOA that they didn’t quite understand. Then you said they made us grab more trial information concerning RO in our trial to try to understand. Therefore extending our trial unnecessarily because it wasn’t in the trial pre-protocol. It was added after... that is what I understand. So it really falls on us that we offered a test to help validate our position for our BLA and they the FDA agreed with us and asked us to verify the history of the testing and put it back on us to extend the length of the trial with this testing since we brought it forward. Well, we screwed ourself it seems. The FDA only accepted what we were trying to show them results for and then we accepted the new protocol. Problem was that it wasn’t really what the FDA wanted when all said and done and the RO testing became the problem. Wasn’t proper for whatever reason. It didn’t meet the grade of proper testing for whatever reason. Now you can correct me if I am wrong on these perceptions and I will gladly accept any and all criticism. I believe I am only repeating what you have said and I have learned on this board.
As for the CD-12... we had results recently that look really good but are on a small group or subset of critical patients that is only 62 people of the 384 people in the trial. Now I wish with all my heart that that was enough for a EUA but as we know now it is not enough and it’s not in the FDA guidelines to give an EUA on anything but a primary endpoint. We now also know that we didn’t meet as a whole on the trial any endpoints primary or other. We also know that others didn’t meet end points but got an EUA. It could be very well our pushing that has already cost us that EUA. We will never know that. One thing we can surmise is that it didn’t help us being pushy with the FDA or maybe we would have the EUA. So we essentially struck out and yet we believe we should continue to push when we are sitting in a lose/lose situation? How can we use our judgement better? My belief is we let things settle and see where everything settles out to. Still keep our relationship and trials going to fall back on. We have to because that is where we have to perform to get any future approvals.
My opinion is we pushed already and it cost us respect and better judgment on a possible EUA. Because we know it didn’t get us an EUA. Added pressure could very well spread our relationship with the FDA even further apart. That to me is the worst case scenario and is something we can cure if we just stopped on our assault of slamming the FDA. Now I know opinions differ and we are all entitled to our opinions. My opinion of stopping the pushing and letting things settle is just what I believe is the best case for us as a company to keep what little relationship we might have left. I think it is ultra important to have a great relationship with the regulators. I am a people person and have negotiated contracts in a groups atmosphere and have a good understanding of personal grudges and how they affect negotiations. I personally never push to get my way but strive to show my position and make everyone understand why my position is my position or just the opposite in asking someone to explain their position to me like I am a 4 year old and just don’t understand. Being understanding of everyone’s position is the best place to be in an amicable agreement or a way to achieve that agreement. It’s alway give and take when negotiating and you never get everything you want. But start high and settle in the middle. That’s my best advice. We have pushed hard and high and we need to settle down and see what will become of our future and what mending we will have to do in order to acquire approvals for the indications of Leronlimab in the future.
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