What is FDA?

This is the U.S. Food and Drug Administration: U.S. Food and Drug Administration], abbreviation: FDA, a federal government agency directly under the jurisdiction of the U.S. Department of Health and Human Services, its main function is to be responsible for the supervision and management of food, dietary supplements, drugs, vaccines, biomedical preparations, blood preparations, medical equipment, radioactive equipment, veterinary drugs and cosmetics produced and imported in the United States.

To put it simply: in the United States, all new drugs, new medical devices, and treatments must be approved by the FDA for clinical trials and marketing.

In 1990, the United States is the world's largest pharmaceutical market. Drugs that can be sold in the United States are drugs that can be used internationally. Drugs that can be monitored and marketed by the FDA can easily pass the health requirements of other countries in the world.

This means that as long as a new drug can be marketed through FDA regulation, it means that the new drug can be passed and marketed globally.

Although the effect of this [sildenafil citrate] "invented" by Abel is very magical, the technical details of the patent look very good.

However, the experiments of medicine and medicine are very strict, and formal countries need to pass very strict clinical experiments. And a drug, it is very simple to have a strong curative effect, and the effects of various drugs in major biological or medical laboratories are many times stronger than those sold outside.

But they are almost impossible to sell, because either they have huge side effects, or they are extremely difficult to manufacture, or they cannot pass various health regulations. This [sildenafil citrate] looks very effective, but it must also be able to pass the supervision and be officially listed before it can create benefits.

Before that.

It's a question mark.

Pfizer and Takeda were aggressive because of their relatively small companies. When they heard that there was such a miraculous drug, they knew that it was a huge new drug, so of course they would immediately think about grabbing it first, and then plan for the rest slowly.

But representatives of two other pharmaceutical companies, they are now the first and second in the world. Many of the very good medicines that are sold outside now belong to the two of them. In this case, although they knew that [sildenafil citrate] would be popular as soon as it was listed, they were still able to maintain a certain level of calm and sobriety.

It's just that this calmness and sobriety have completely disappeared after seeing that the FDA application has reached the [Special Evaluation Protocol] stage of Step 5.

Throughout the years, as long as the drug can pass this hurdle, few have failed the FDA's application. Because in the previous steps 4 and 3, two clinical trials have already passed. The next 6th level and the last clinical trial can pass the first two times, and there will generally be no problems in this 6th time. As long as you pass this 6th level, the remaining 7th and last levels will cost some money and take some time, and you can pass it without difficulty.

That's when the drug will be on the market.

A total of eight steps of FDA application is over, and if the last hurdle is passed, the new drug can be marketed and sold in the United States, that is, from the idea and idea to the market, the drug will take 6.5 years or 6 and a half years at the earliest.

This is also the reason why the actual market value of many companies in the preclinical stage with novel concepts is not high: 1) the cycle is long, and 2) there are too many uncertainties in the middle.

Of course, the above time estimates are based on extremely normal and ideal conditions. Although the FDA has many policies to promote the development of new drugs, such as accelerated tracks, rapid review, priority review, breakthrough treatments, etc., there is often a saying of the "double ten rule" for new drugs, that is, "ten years, one billion costs".

The billion here is in dollars.

Pharmaceutical companies are also one of the most expensive and expensive types of experiments in the world. Compared with the experimental R&D investment of pharmaceutical companies, the investment of later Internet high-tech companies is simply scum.

According to the normal process, Abel's drug will pass through the FDA and then be marketed, and it will take 6 years at the earliest. But Abel can be said to be abnormal in some ways. At least in the first few steps, except for clinical trials, he is "abnormal".

The first step in coming up with this new drug is to [preclinical trial stage]. Generally, it is carried out on animals, such as: mice, pigs, monkeys, etc., and it generally takes 3-5 years.

This level is the longest initial research and development level, and in this level, Abel is useless for a day - nonsense, after all, it is plagiarism, knowing the effect, and doing a fart experimental conjecture, directly follow the most correct steps.

He directly started the second step: [Investigational New Drug Application].

This hurdle is that if the preclinical phase of the trial on animals has achieved good results, it can file an IND, that is, an investigational new drug application can be filed. The time for application approval is one month, which can reach one week under the special convenience policy, and Abel is one week.

Next is the most troublesome, the first clinical trial and the second clinical trial, that is, the third and fourth levels.

In these two passes, Abel took advantage of the FDA's legal policy to facilitate scientists, and it took a month to get the normal correction of others that needed to reach more than a year to pass.

From the plagiarism experiment to the finished product of the experiment, it is necessary to start submitting to the FDA, and now the fifth level of submission, under normal circumstances, it will take at least 6 years.

Abel has used advanced wisdom in a way that has been helped by the FDA's regulatory efforts to help scientists pass the various preferential accommodations required as soon as possible.

It took him two months to pass the first five levels that others needed at least 6 years to pass, and suddenly came to the last three levels that only took half a year to complete.

In other words, if you get this technology and patent from Abel now, as long as there are no accidents, the drug can be marketed immediately after half a year!

As for why Abel, an ordinary Chinese college student in his previous life, was able to do the experiment of [sildenafil citrate] immediately after being reborn, and it only took more than a month to do it, this matter will be mentioned later.

In a word.

After hearing that Abel's "invention" - [sildenafil citrate] has reached the 5th level of the FDA, both the representatives of the two pharmaceutical companies that were eager before, or the representatives of the two pharmaceutical companies that were a little arrogant before, suddenly understood the value of this drug.

The representative of Bristol-Myers Squibb Pharmaceutical, the world's No. 1 pharmaceutical company, immediately stood up, "Bristol-Myers Squibb has been the world's No. 1 pharmaceutical company for three years, and we can give Mr. Sephorosa the best treatment and the best price." Mr. Sephorosa, please cooperate with us. ”

Not to be outdone, the representative of Merck Medicine immediately followed: "Although Merck is the second largest pharmaceutical company in the world. But because it's second, we're more willing to pay a lot of money. Believe me, you get more out of choosing MSD, dear Mr. Sephorosa!"

Naturally, Takeda and Pfizer were not to be outdone, and the two representatives also chattered.

See this kind of performance on behalf of four pharmaceutical companies.

Alvertelli was very excited, and unlike Cameron Diaz, a somewhat ignorant assistant in life, he knew the deep energy of the four representatives in front of him.

To be able to get these pharmaceutical companies interested, it was clear that Alvertelli felt that his boss had made it!

Cameron Diaz bowed his head.

She didn't understand academic issues, and she didn't know what the FDA and international patent PC T application was, she only knew what the word ED meant just now.

She looked at Abel with some sympathy in her eyes.

So tall, so strong, and so young and handsome. The body looks so good, and you actually have this disease?

What? You say you don't have it?

If you don't have this disease, why do you want to research this medicine? Just to sell it for money?

She thought to herself.

Abel didn't notice the little assistant's expression and eyes, and he watched with satisfaction the changing expressions of the four medical representatives, especially Bristol-Myers Squibb and Merck, who were a little condescending.

I feel refreshed in my heart.

That's right, that's what I want! That's what I should enjoy! No matter where I go, I'm always sought after!

If it can't be sought after!

Then please hate me because you are afraid of me!

This is the meaning of life!

Do it all over again, and get something like this, if you can't live wantonly for the rest of your life, enjoy everything you deserve.

Then don't be born again!

Looking at the ball of light in front of him, which only he could see, Abel was firm in his heart:

With it, this life itself is Tony Stark + Adrian Cowell!

The king of technology and the king of Hollywood!