"The FDA actually agreed?"
Wei Kang was a little surprised. He just casually mentioned two conditions that he wanted to try, and he didn't expect the other party to actually agree.
Unexpectedly, the FDA actually agreed.
Not only has the ban on sales of painkillers been lifted, but clinical data can also be submitted directly to the FDA and applied for listing through the fast track.
In addition, three cardiovascular and cerebrovascular drugs, namely antihypertensive drugs, anticoagulants and antithrombotic drugs, are all in phase III clinical trials and can be conducted overseas clinical trials together in Eagle Country.
As for the special medicines for cat abdominal transmission, anti-allergy medicines, scar removal creams, hair removal creams and other medicines, they are also included in the package application list.
"Is the FDA so kind?"
Wei Kang was puzzled. When did the FDA become so talkative?
Generally, the FDA only welcomes life-saving drugs that can treat malignant diseases, such as anti-cancer drugs.
Or a drug that is unique and has no competition, such as a specific drug for Alzheimer’s disease.
As for other drugs, the FDA's review standards have always been very strict, and it is better to be deficient than indiscriminate.
Especially drugs like analgesics, which are highly replaceable and involve a lot of interests, have always been unselfish and banned their sales, leaving no room for accommodation.
So this 180-degree turn in his attentive attitude really puzzled Wei Kang.
He vaguely felt that something was wrong, but he couldn't see it for the moment, so he could only put it aside for the time being.
Anyway, as long as you abide by the law and don't leave any excuses to the other party.
I believe that the other party can't do anything to him.
Next, Sanqing launched overseas clinical trials of a batch of new drugs.
This time, the FDA very generously allowed Sanqing to provide clinical trial data from China. In Eagle Country, it only needs to supplement the clinical trials of different races such as whites and blacks, in order to achieve the universal applicability of the drug to multiple races.
In this way, the number of clinical patients required will be much smaller, which can greatly shorten the approval time.
The FDA generally has very strict requirements for Phase III clinical trials of drugs, which usually require the participation of thousands of people and a randomized double-blind control.
Randomized double-blind control is the gold standard for clinical trials. All patients are randomly divided into two groups, one group takes drug treatment, and the other group takes a placebo.
As for whether the patient took the drug or a placebo, the subjects did not know, nor did the treating doctors. Only a third-party independent monitoring member knew which group the subjects were assigned to.
Only in this way can the effectiveness of clinical trials be ensured to the greatest extent possible.
A drug needs to be at least 30% more effective than the placebo group in phase III trials in order to be called clear and credible effectiveness.
Moreover, statistical analysis must show that this effectiveness is supported by reliable data and is not due to random luck.
According to the FDA's previous instructions, it is expected to be approved if the effectiveness reaches 30%.
Of course, the higher the effectiveness, the better.
However, in some acute and severe diseases, double-blind drug trials are undoubtedly a bloody and cruel experiment.
The patient is about to die, but is assigned to the control group and takes a placebo. This often causes huge ethical controversies and is considered unethical behavior.
Therefore, anti-cancer drugs and other drugs before Sanqing did not undergo double-blind experiments.
Because the probability of self-healing of late-stage cancer is close to 0, and the objective effectiveness of placebo is close to 0. If a drug can achieve a very high objective effectiveness in treatment, it has almost a 100% probability of being effective. This does not require double blinding. It can also be seen by comparison.
This is different from illnesses such as colds and coughs. Most of these diseases can be cured by themselves relying on the body's immunity. More than 90% of people will heal on their own without any drugs. If drug treatment is given, the self-healing rate will be higher. will be higher.
Therefore, for this disease, which can be cured by the human immune system, if we want to obtain definite evidence of the effect of the drug, we must conduct a double-blind controlled clinical trial, so as not to mistake the self-healing immunity after taking a placebo for a drug. therapeutic function.
As long as the objective effectiveness of drugs such as anti-cancer drugs is higher than that of standard therapies, the sample size reaches a certain number, and the side effects are tolerable, they can obtain breakthrough therapy designation from the FDA and be prioritized for review and rapid marketing.
This time, the thalassemia gene drug also followed the green channel for innovation approval.
It skipped countless tedious and disgusting approval procedures and entered the third clinical phase as soon as possible.
And considering that thalassemia is a rare disease, the number of clinical patients has also been significantly reduced, only a few dozen people are enough.
In short, the green light is given throughout the entire process, and we strive to promote the marketing of this new drug as quickly as possible.
****
Eagle Country, West Virginia.
This is one of the states with the worst painkiller epidemic in the Eagle Country and has been called the epicenter of the opioid crisis.
Alexander limped into the clinic and came to the doctor.
"Doctor, I'm here again. I've finished using the painkillers, but my thigh still hurts. Please give me some more medicine."
He had been here several times and spoke to the doctor with ease.
The doctor said solemnly: "Didn't I just give you the medicine for two weeks? Why did you finish it so quickly?"
Alexander said with a playful smile: "The effect of this medicine will not last long after taking it for a long time. I will take an extra pill occasionally and I will feel much better."
The doctor suddenly felt a headache. Another patient addicted to painkillers. If he continued to eat like this, there was really no hope.
He couldn't help but shook his head and said: "This medicine is addictive. Don't take too much. You don't want to overdose and die at home like little George."
Alexander shrugged nonchalantly and said, "Do you think I do? I have a chronic problem with sciatica. I can only take painkillers to prevent myself from dying of pain."
The doctor knew that he was right. Most people in the Eagle Country were like this. Medical treatment was too expensive. If they had a minor problem, they would just take a few painkillers and that would solve the problem.
Especially for chronic diseases such as sciatica, there is no particularly good cure. The only way to relieve it is to take painkillers.
He took out his pen and was about to write a prescription when he suddenly hesitated: "A new painkiller has been launched recently and it is very effective. Let me prescribe this for you."
Alexander wondered: "Why do you need to change my dressing? I was eating well last time."
The doctor signed his signature: "Listen to me, this medicine is not addictive, and you don't have to worry about dying in the garbage in the future."
Alexander was stunned, with a look of disbelief on his face: "Are there any non-addictive painkillers? Then why didn't you prescribe them to me before?"
The doctor lowered his voice and said: "This drug has been on the market for a while. It was banned by the FDA before and could not be prescribed to you. Now that the ban has been lifted, you can buy it."
Alexander was furious after hearing this: "Damn the FDA, they won't allow the sale of such good painkillers, and they only give us addictive junk medicine. It's totally unreasonable. I must go online to expose its ugly face of disregarding human life."
****
Eagle Country, California.
Solomon has been waiting for several months. At first, he was looking forward to receiving a call from Sanqing soon to go to China to participate in clinical trials of thalassemia gene drugs.
However, he did not receive a call until all his acquaintances had recovered from illness and returned home.
The endless waiting exhausted all his patience, and he had begun to doubt life.
At this moment, he finally received a call from the far east.
The sweet, fairy-like voice on the phone told him that he could participate in the Phase III clinical trial in Eagle Country.
This was more or less the same. It saved him a lot of traveling. He snorted in his heart, feeling that the impatience of waiting for a long time was finally relieved.
Especially after seeing the name of the cooperating clinical hospital - Mayo Clinic, he smiled with satisfaction.
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