It is an interesting article, one thing I noticed was the pressure from the government to help industry create jobs by instructing government agencies the be more supportive to industry. The FDA specifically was to help with approvals rather than stand strong against drugs tat are not only ineffective but un safe as well. It is depressing that this whistle blower has had to wait 10 years to now show what happens when these drugs do get approved. It looks like this whistleblower knew what this ceo was up to before this particular drug was in trials.
It is also interesting how this CEO navigated the process, getting drugs approved, hiding actual trial data and getting the company sold for billions to BP. Looks like this is a pattern for these drugs. I can see how BP is getting tired of buying these drugs for billions, realizing it does not work, getting sued and losing hundreds of millions and selling the drug off or scrapping it. These CEOs seem to repeat this process and stay one step ahead of the downfall.
Where does this leave cytodyn? We don’t have the financial influence to push through trials into approval. Sounds like cytodyn has in the past hired these ex-fda employees working as consultants with no results from that either. You would think with the safety of leronlimab it would be easy, even if leronlimab was not that effective. My depressing assumption is that the politics is way more important than the trial data. The fda seems to now be back in stall mode for anything that is not politically backed. I don’t mean politically from politicians, I mean from the politics of BP and the high levels of the FDA. It also seems that the scientists that actually do the trial reviews are good people that believe in what they are doing. I think Nader is being honest that cytodyn does have a good relationship with these people. However once the data has to go up the hierarchy it not going as it should.
I don’t think we can fix this, corrupt ness based on a government agency that simply is playing way too safe in order to stall an approval is hard to expose. We are not going to find an email instructing those responsible to slow roll or to not approve leronlimab specifically. We also can’t keep thinking tat just because some other drug got approved, leronlimab should also. The fda clearly separates drug applications as if other drugs and past trial data does not exist, unless the insist on leronlimab to be used in conjunction with SOC. It is strange that the fda being irresponsibly too safe with leronlimab when leronlimabs strength is its safety. Safer that aspirin for craps sake.
It is also interesting how this CEO navigated the process, getting drugs approved, hiding actual trial data and getting the company sold for billions to BP. Looks like this is a pattern for these drugs. I can see how BP is getting tired of buying these drugs for billions, realizing it does not work, getting sued and losing hundreds of millions and selling the drug off or scrapping it. These CEOs seem to repeat this process and stay one step ahead of the downfall.
Where does this leave cytodyn? We don’t have the financial influence to push through trials into approval. Sounds like cytodyn has in the past hired these ex-fda employees working as consultants with no results from that either. You would think with the safety of leronlimab it would be easy, even if leronlimab was not that effective. My depressing assumption is that the politics is way more important than the trial data. The fda seems to now be back in stall mode for anything that is not politically backed. I don’t mean politically from politicians, I mean from the politics of BP and the high levels of the FDA. It also seems that the scientists that actually do the trial reviews are good people that believe in what they are doing. I think Nader is being honest that cytodyn does have a good relationship with these people. However once the data has to go up the hierarchy it not going as it should.
I don’t think we can fix this, corrupt ness based on a government agency that simply is playing way too safe in order to stall an approval is hard to expose. We are not going to find an email instructing those responsible to slow roll or to not approve leronlimab specifically. We also can’t keep thinking tat just because some other drug got approved, leronlimab should also. The fda clearly separates drug applications as if other drugs and past trial data does not exist, unless the insist on leronlimab to be used in conjunction with SOC. It is strange that the fda being irresponsibly too safe with leronlimab when leronlimabs strength is its safety. Safer that aspirin for craps sake.
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