I understand the process but we live in a different world. Tell me how Remdisivir got their approvals by proper processes and not having to repeat their one of many trials that showed a positive result and the others stopped prior to being revealed internally as failures. Why didn’t they have to do a phase 4 proof. How did convalescent plasma sneak in with minimal effect?
The fact is we live in what I consider a different time and it’s not just pandemic time. Historically none of the EUA’s would of been approved in a different time even with a pandemic. But the political pressure on the FDA is immense and nothing isn’t impossible. We can call this “ Trumps World “ I am not putting him down politically. But our world is most definitely different with him at the helm. You can say process process process. But I will just say. Trump will change those rules if it fits his agenda. He has done it over and over and he will do it again and again. I am not a fan of him really but I am a realist and when he wants something real like Leronlimab. He will need to back up the reason to approve and not just say that Nader said it had a perfect safety record. His only way to have the public view it as safe IMO is to approve HIV for the use of the safety profile to be documented. The hoops we would have to jump through will be pulled down so we could kindly walk our way to approval. That’s what I would call Trumps World. Anything is possible!.
The simultaneous approval would go along way to getting the confidence of the public back. That’s what he needs. It’s what we all desire. It’s just a matter of telling him that’s what can happen. Then he will make it so... Don’t discount what the Donald can do. Just be amazed at what he has done already and then speculate. Is it possible? Surely you have to believe that he will do anything to gain back the public opinion?
Maybe this is all fiction? Or is it? I give it 50/50 that if the S/C results are good or great that we miraculously get a approval of HIV simultaneously. To me... I am amazed at what he has done already. I believe this isn’t a reach in “ Trumps World “ when politics are involved anything is possible.
By the way, he has upset the Big Pharma apple cart with price match world prices going forward. He is ready to piss them off again if it benefits his agenda. Big Pharma power to hold us back will surely go away now with impact results to make him a hero.
Just remember who I am. The overly optimistic person who’s glass does runneth over.
Probably not likely to happen but I can share my dreams right?
The fact is we live in what I consider a different time and it’s not just pandemic time. Historically none of the EUA’s would of been approved in a different time even with a pandemic. But the political pressure on the FDA is immense and nothing isn’t impossible. We can call this “ Trumps World “ I am not putting him down politically. But our world is most definitely different with him at the helm. You can say process process process. But I will just say. Trump will change those rules if it fits his agenda. He has done it over and over and he will do it again and again. I am not a fan of him really but I am a realist and when he wants something real like Leronlimab. He will need to back up the reason to approve and not just say that Nader said it had a perfect safety record. His only way to have the public view it as safe IMO is to approve HIV for the use of the safety profile to be documented. The hoops we would have to jump through will be pulled down so we could kindly walk our way to approval. That’s what I would call Trumps World. Anything is possible!.
The simultaneous approval would go along way to getting the confidence of the public back. That’s what he needs. It’s what we all desire. It’s just a matter of telling him that’s what can happen. Then he will make it so... Don’t discount what the Donald can do. Just be amazed at what he has done already and then speculate. Is it possible? Surely you have to believe that he will do anything to gain back the public opinion?
Maybe this is all fiction? Or is it? I give it 50/50 that if the S/C results are good or great that we miraculously get a approval of HIV simultaneously. To me... I am amazed at what he has done already. I believe this isn’t a reach in “ Trumps World “ when politics are involved anything is possible.
By the way, he has upset the Big Pharma apple cart with price match world prices going forward. He is ready to piss them off again if it benefits his agenda. Big Pharma power to hold us back will surely go away now with impact results to make him a hero.
Just remember who I am. The overly optimistic person who’s glass does runneth over.
Probably not likely to happen but I can share my dreams right?
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