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Posted On: 05/17/2021 4:33:42 PM
Post# of 148899
FDA is a sore loser:
- Everybody with a brain in their heads knows that the drug is SAFE. Not a single mention of this. Why?
- No mention of the emergency usage lives that were saved? CRIMINAL.
- Clearly the end points were not met, but is this the first time in the history of a good drug that has shown amazing results, that failed to meet end points? Then the the SO HELPFUL FDA had to retort with a DAMAGING public press release? Why?
- WE know that 'p' value trials are easier to pass if you have the money to increase the test patients into the thousands to get the 'p' value to almost be meaningless. Small biotech companies cannot afford to do this. Is 'p' value the only way to ascertain efficacy, especially if the drug is ultra safe?
- BOTTOM LINE, read the second to the last para it says it all:
"IF Cytodyn plans further studies of Leronlimab to determine whether the drug can provide clinical benefit to individuals with Covid-19, FDA will continue to provide advice to the company on their development program."
NO THANK YOU FDA!! CYTODYN has walked away ....
We have seen the help you provided for the HIV trials. We now have seen the help you provided in designing the CD-10 (which was a joke given that most mild patients would improve anyway and no secondary endpoints for data after 3 days where there was obvious improvement instead using average of 14 days!). CD-12 showed amazing results in above 65 age group, but for the faulty design of the test to distort the results that anyone can see through, except for the FDA.
THIS REACTION BY THE FDA IS DUE TO TWO FACTORS:
1) The publicity and pressure being brought onto the inept FDA (best case). I have a feeling this has been extremely effective. Their statement has been very carefully worded, maybe accurate but far from being the complete picture as we all know. It will still be their downfall at the end.
2) CYTODYN, finally not being suckered into additional, expensive, time delaying tactics by the FDA (and whomever they maybe covering for). CYTODYN receiving favorable testing venues internationally, with reputable partners, has to have PISSED OFF the FDA to no end! REJECTION is cruel, especially if you feel you are indispensable!
MAY CYTODYN PROVE ITSELF IN UPCOMING INTERNATIONAL TESTING. However, I fear that this FDA statement will provide a lot of fuel for BIG PHARMA to try to stop or to disrupt and slow down these tests. Should make a great Harvard Business Review case study someday, I hope.
FDA will have to someday stand up and face the thousand of deaths that they may have allowed by their tactics. Not that this is likely, but congressional hearings can also be pretty damning.
TIME TO MOVE ON!! GLTA!!
- Everybody with a brain in their heads knows that the drug is SAFE. Not a single mention of this. Why?
- No mention of the emergency usage lives that were saved? CRIMINAL.
- Clearly the end points were not met, but is this the first time in the history of a good drug that has shown amazing results, that failed to meet end points? Then the the SO HELPFUL FDA had to retort with a DAMAGING public press release? Why?
- WE know that 'p' value trials are easier to pass if you have the money to increase the test patients into the thousands to get the 'p' value to almost be meaningless. Small biotech companies cannot afford to do this. Is 'p' value the only way to ascertain efficacy, especially if the drug is ultra safe?
- BOTTOM LINE, read the second to the last para it says it all:
"IF Cytodyn plans further studies of Leronlimab to determine whether the drug can provide clinical benefit to individuals with Covid-19, FDA will continue to provide advice to the company on their development program."
NO THANK YOU FDA!! CYTODYN has walked away ....
We have seen the help you provided for the HIV trials. We now have seen the help you provided in designing the CD-10 (which was a joke given that most mild patients would improve anyway and no secondary endpoints for data after 3 days where there was obvious improvement instead using average of 14 days!). CD-12 showed amazing results in above 65 age group, but for the faulty design of the test to distort the results that anyone can see through, except for the FDA.
THIS REACTION BY THE FDA IS DUE TO TWO FACTORS:
1) The publicity and pressure being brought onto the inept FDA (best case). I have a feeling this has been extremely effective. Their statement has been very carefully worded, maybe accurate but far from being the complete picture as we all know. It will still be their downfall at the end.
2) CYTODYN, finally not being suckered into additional, expensive, time delaying tactics by the FDA (and whomever they maybe covering for). CYTODYN receiving favorable testing venues internationally, with reputable partners, has to have PISSED OFF the FDA to no end! REJECTION is cruel, especially if you feel you are indispensable!
MAY CYTODYN PROVE ITSELF IN UPCOMING INTERNATIONAL TESTING. However, I fear that this FDA statement will provide a lot of fuel for BIG PHARMA to try to stop or to disrupt and slow down these tests. Should make a great Harvard Business Review case study someday, I hope.
FDA will have to someday stand up and face the thousand of deaths that they may have allowed by their tactics. Not that this is likely, but congressional hearings can also be pretty damning.
TIME TO MOVE ON!! GLTA!!
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