It does happen a drug in a clinical trial performs great and the trial is stopped. What usually happens when that happy event occurs is the control group is moved over to the new drug. But keep in mind many drugs are being tested for chronic conditions like cancer, diabetes, or heart disease. The miracle drug doesn’t cure but just does a better job at holding the underlying disease at bay.
This is a bit different because it is a bit like Tamiflu. You use it within a few days when symptoms appear. When this trial was stopped, most likely there was no control group to move onto the drug. Those that didn’t get the drug went into their Covid infection and either recovered or not.
Manufacturing is not crazy at all. The drugs made for clinical trials are made in small batches which require their own control and checks to make sure the drug can be made without impurities and with the correct dose. It’s easy to forget but it really is amazing that you can go to a dollar store, buy a bottle of 350mg aspirin and every single pill in that bottle will have no more or no less than 350mg of active ingredient. The set up to make a few thousand pills for the purpose of a trial is not the same as the prime time type set up to churn those pills out by the millions.
The FDA approves both the drug and the company’s manufacturing operation. That begs the question does Pfizer have their manufacturing ready to go today, just waiting for FDA inspectors to say “turn it on”? I don’t know, there’s a lot of different drugs being tested and I doubt many companies can afford to keep a factory tooled and set to make the pill but otherwise idle the moment a good result comes in from the trials. Most likely the factories are making other pills, many probably more important than simple aspirin, and it is not a simple matter of just flipping a switch and changing over to this pill. I note this trial was completed earlier than expected so possibly Pfizer had slotted manufacturing time later on, in expectation the trial would be ongoing right now. So this is also fairly a question of when can Pfizer bring their manufacturing online and I’m sure they are more than eager to do so.
It does happen a drug in a clinical trial performs great and the trial is stopped. What usually happens when that happy event occurs is the control group is moved over to the new drug. But keep in mind many drugs are being tested for chronic conditions like cancer, diabetes, or heart disease. The miracle drug doesn’t cure but just does a better job at holding the underlying disease at bay.
This is a bit different because it is a bit like Tamiflu. You use it within a few days when symptoms appear. When this trial was stopped, most likely there was no control group to move onto the drug. Those that didn’t get the drug went into their Covid infection and either recovered or not.
Manufacturing is not crazy at all. The drugs made for clinical trials are made in small batches which require their own control and checks to make sure the drug can be made without impurities and with the correct dose. It’s easy to forget but it really is amazing that you can go to a dollar store, buy a bottle of 350mg aspirin and every single pill in that bottle will have no more or no less than 350mg of active ingredient. The set up to make a few thousand pills for the purpose of a trial is not the same as the prime time type set up to churn those pills out by the millions.
The FDA approves both the drug and the company’s manufacturing operation. That begs the question does Pfizer have their manufacturing ready to go today, just waiting for FDA inspectors to say “turn it on”? I don’t know, there’s a lot of different drugs being tested and I doubt many companies can afford to keep a factory tooled and set to make the pill but otherwise idle the moment a good result comes in from the trials. Most likely the factories are making other pills, many probably more important than simple aspirin, and it is not a simple matter of just flipping a switch and changing over to this pill. I note this trial was completed earlier than expected so possibly Pfizer had slotted manufacturing time later on, in expectation the trial would be ongoing right now. So this is also fairly a question of when can Pfizer bring their manufacturing online and I’m sure they are more than eager to do so.