Regarding the FDA - They have a job to do. It
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Posted On: 11/12/2020 2:17:01 PM
Re: Cassandra X #65312
Regarding the FDA -
They have a job to do. It is their job to make Cytodyn jump thru hoops (Trials, safety, efficacy, supply, distribution, etc.) Do they treat us differently than other pharma companies, especially BP? Of course they do!
To begin with, each pharma is unique and brings to the FDA a request for specific considerations. Has the FDA given us some big breaks? Absolutely! We are a small, unproved company with one unproved drug. We are a one-trick pony, literally.
The FDA allowed Cytodyn to proceed to Phase 2 and 3 trials based on the trial work done for HIV. They didn't have to do that and they didn't have to keep our trial populations small.
Every hoop that the FDA has asked us to jump thru Pourhassen has said, "We can do that." He has no complaints, rather he is grateful that we are not being asked to do things out of our reach and that the FDA has given guidance to him about how to navigate the maze.
Has the FDA misled Cytodyn into some blind alleys? Not really. You can expect some inconsistency from a large outfit like the FDA as you deal with different people who see thing differently. Cytodyn has sought certain shortcuts to the goal of approval for some things and they have been denied but not always. EUA after Phase 2, no. EUA after interim review half way with Phase 3, no - but try again at 75% enrollment!
They could have said we need a trial with 3000 patients and you have to finish the whole enrollment. Wouldn't that have been fun!
No, we have gotten the breaks we have and all we have been asked it to jump thru those hoops - just take the time and make the effort required and if Leronlimab if the right stuff, they can not deny your progress forward.
In the case with this pandemic, OWS has said they will underwrite us if we can't handle things ourselves. What a corrupt, evil outfit!
So stop the self-serving backbiting of Cytodyn and the FDA and give the process (a hugely truncated process!) time to work!
They have a job to do. It is their job to make Cytodyn jump thru hoops (Trials, safety, efficacy, supply, distribution, etc.) Do they treat us differently than other pharma companies, especially BP? Of course they do!
To begin with, each pharma is unique and brings to the FDA a request for specific considerations. Has the FDA given us some big breaks? Absolutely! We are a small, unproved company with one unproved drug. We are a one-trick pony, literally.
The FDA allowed Cytodyn to proceed to Phase 2 and 3 trials based on the trial work done for HIV. They didn't have to do that and they didn't have to keep our trial populations small.
Every hoop that the FDA has asked us to jump thru Pourhassen has said, "We can do that." He has no complaints, rather he is grateful that we are not being asked to do things out of our reach and that the FDA has given guidance to him about how to navigate the maze.
Has the FDA misled Cytodyn into some blind alleys? Not really. You can expect some inconsistency from a large outfit like the FDA as you deal with different people who see thing differently. Cytodyn has sought certain shortcuts to the goal of approval for some things and they have been denied but not always. EUA after Phase 2, no. EUA after interim review half way with Phase 3, no - but try again at 75% enrollment!
They could have said we need a trial with 3000 patients and you have to finish the whole enrollment. Wouldn't that have been fun!
No, we have gotten the breaks we have and all we have been asked it to jump thru those hoops - just take the time and make the effort required and if Leronlimab if the right stuff, they can not deny your progress forward.
In the case with this pandemic, OWS has said they will underwrite us if we can't handle things ourselves. What a corrupt, evil outfit!
So stop the self-serving backbiting of Cytodyn and the FDA and give the process (a hugely truncated process!) time to work!
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