Rebirth of the God-level Xueba

"Professor." Huang Mao gently knocked on the door and entered Yang Rui's office.

"Oh, Huang Mao, what's the matter?" Yang Rui rubbed his temples, still immersed in the fatigue of continuous phone communication.

It is not a simple matter to replace the test items of a new drug. Many new drugs will try to add new indications after they start to be sold. However, if a new drug has not passed clinical trials and wants to change indications, it is tantamount to a failure.

The FDA will only be more harsh on new drugs that fail re-examination.

Most of the time, it is not approved.

Historically, Pfizer also took a lot of effort to change the indication of sildenafil. It took more than half a year and an inexplicable price to let the FDA let go.

Compared with Pfizer, the largest pharmaceutical company in the United States, Greenstone Corner, which cooperates with Sinovel, is just a small guy. Its scale is less than one-tenth that of Pfizer. For a customer company, there are less than 30 congressmen who can influence it, and it lacks hardcore supporters, and its public relations funds and industry influence are not outstanding.

Yang Rui can only take side measures to influence the FDA.

To this end, Yang Rui published an article "science".

Indeed, it is very difficult to publish in the world's three major journals "Science". Scholars from any country at any time want to publish an article in "Science".

A scholar assumes that he started to do experiments at the age of 40 to accumulate data, and by the age of 50, the accumulated data is only eligible for submission to "Science", and whether it can be published is another matter.

"Science" is aimed at all fields, but everything in the field of science, from traditional physical chemistry, popular computer hardware and software, uncommon paleontological excavation, and Egyptian writing research, is eligible, and it is the most extensive in CNS. It can be said that, except for the pure liberal arts projects involved in liberal arts monks, anyone has the hope of publishing "Science".

And the number of submissions per year, from the perspective of papers, is also an astronomical figure.

Fortunately, only a hundred articles are published every year. The probability is so low that most scholars regard it as good luck.

Only Yang Rui can hold down the G-spot of "science" if he wants to.

The title of Nobel laureate is only one aspect - but it has to be said that its role is very important, especially for young and active Nobel laureates, whose articles fall into the editor's hands from the moment From the very beginning, it must be given great attention.

The specificity of sildenafil, especially the prevalence of nitric oxide-related topics, has brought more recognition.

Nitric oxide would have been named Molecule of the Year by Science in '92 if no additional changes had been made.

In recent years, the topic of nitric oxide has become too hot.

Any relevant research will be highly regarded in any journal.

Not to mention the nitric oxide compounds brought by the Nobel Prize winners.

The reason why sildenafil can make the cavernous body harden is that it stimulates the body to release nitric oxide.

From this perspective, taking Viagra is to inflate yourself.

What "Science" wants to publish is the inflation process.

Pfizer may be very good in the business field, but they can't do it and don't need to let "Science" do what they want.

Sildenafil was just a useful compound screened out by a commercial company before. Although it sold 180 million US dollars, it was a lot, but in the eyes of the scientific community, it may not have the weight of "being favored by Yang Rui".

The chemists responsible for clinical experiments on sildenafil are only the fourth-rate scientists in the world—the first-rate scientists receive the Nobel Prize, the second-rate ones are waiting for the Nobel Prize, the third-rate ones give lectures in famous schools, and the fourth-rate ones are tenured professors—the fourth-rate scientists are the public Although it is also world-class in the eyes, "Science" has never been seen by the public.

However, when Comrade Yang Rui, the world's first-class scientist, analyzed the whole of sildenafil,

"Science" also had to give way when making a new description from the perspective of the nitric oxide theory.

For a super-ben like Yang Rui, he just published a review of nitric oxide, and "Science" might even publish it, let alone a paper with complete data and novel ideas.

The most important thing about a thesis is actually the idea.

When it comes time to study for graduate school or Ph.D., how do you distinguish between a good student and a student? Is it wonderful to see who kills mice? It is nothing more than whoever has the best thinking and who is the most powerful.

The same is true for scholars and professors. All the work is done by scientific research dogs. The workload is nothing more than using a few more scientific research dogs and spending 1,200 more per month. The division of classes depends on the way of thinking in the end.

And when Yang Rui needs to come up with subtle ideas, it's not that he is not humble, the others are scumbags.

"Science" magazine was also instantly seconds.

Several reviewers contacted the editor at the first time, gave the evaluation of the article's passing, and strongly recommended it - the double anonymity system for scientific research papers is useless in the group of high-end scholars.

Regardless of whether the journal itself can firmly abide by it in front of Nobel Prize-winning scholars, the resources of high-end scholars themselves are enough to break through this barrier.

Like the word "sildenafil", as long as it appears in the paper, everyone will immediately think of Yang Rui.

The news that he spent 180 million to buy Pfizer did not hide it. Anyone who cares about the scientific community can hear some rumors, especially in related circles. Besides, manuscript review is not a closed-book exam, and reviewers also need reference materials. No matter what posture they use to check, it is impossible to miss Yang Rui's news.

The news that "Yang Rui made a new achievement" spread before the latest issue of "Science" was published, forcing "Science" to schedule it as quickly as possible.

In the whole process, Yang Rui didn't need to take the initiative to push it, and it was easily completed.

When the people in Greenstone Corner went to the FDA with "Science", in fact, the scientists of the FDA also received the news.

As far as the FDA is concerned, for pharmaceutical companies, it is indeed a god-like existence, and life and death are not exaggerated. Especially after the 1980s, FDA's authority can be said to be extremely powerful.

However, the FDA is not invulnerable.

Its lifeblood is science.

FDA's independence and authority are based on science, and most of the scientists serving it are well-known experts in the industry.

Of course, these people can stick to their own opinions and make decisions, just like what Yang Rui customized for Lubo that day, but when facing scientific issues, their independence has to be shaken.

Of course, the scientific questions raised by ordinary scholars cannot shake the experts of the FDA.

However, if they are indifferent to the demands of Yang Rui, a Nobel laureate and scholar who is currently active in scientific research, then their reputation and independence will be greatly reduced.

Bureaucracy and procrastination are not allowed when replying to the documents submitted by Yang Rui.

The only reason they can reject Yang Rui is science itself.

This is also the reason why pharmaceutical companies hired Nobel Prize winners one after another after the 1990s. However, the reality is that few pharmaceutical companies can really hire Nobel Prize winners during the active period of scientific research.

The Nobel Prize in Medicine and Physiology is given to up to three people every year, and many of them are given to old men.

Young and middle-aged scholars have a low chance of winning the Nobel Prize, and those who are willing to give up scientific research and go to a pharmaceutical company are really rare.

Even Yang Rui, doing sildenafil is also in the state of part-time jobs - if it weren't for the amazing profits of Viagra, which can save him time, make money, increase research funds, change a drug, Yang Rui, after winning the Nobel Prize, would not be so dedicated try my best.

For the world's first-class scientists, time is the most important resource, and money has long been unimportant.

Rather than discussing the importance of money, it is better to discuss the reality of social wealth—anyway, they take money based on the proportion of GDP.

Sildenafil’s request to change indications has been approved by the FDA at a faster rate than in history—”Science” has published it, and it still takes courage to go against the mainstream scientific community.

This time, the FDA didn't show it.

For Yang Rui, the whole thing was very strenuous, and for Huang Mao, who presided over the clinical experiment, it was stressful.

"Professor, this is the list of volunteers for the second clinical phase." Huang Mao lowered his head, placed a thick notebook on the table, and made a thumping sound.

Yang Rui glanced at it, then frowned: "You must have made a mistake."

No, the thread-bound hardcover thick book is all used to write names...

"A total of 27,427 people." Huang Mao said: "The obviously inappropriate volunteers have been eliminated."

"27,427 people, that's a lot..." Yang Rui guessed that many people would sign up, but he didn't expect so many people.

"It's more than a lot." Huang Mao couldn't help complaining: "I checked the literature, and this kind of clinical trial in foreign countries usually requires hundreds of people to sign up, and most of them are recommended by doctors."

The recommendation of a licensed doctor is very important for the clinical trials of pharmaceutical companies, especially in the second phase of the trial, the safety problem has not been completely resolved, and no trusted doctor can tell you that this is the most appropriate choice. There are only a few projects, let alone sign up.

"Do they know the meaning of the second clinical phase?" Yang Rui couldn't help but said, "We just made a mistake before, do they know the danger?"

"I guess I know." Huang Mao paused, and said, "The problem is not how many of them there are. I can pick them out if there are too many of them. Just look at the identities of these people."

Huang Mao opened the thread-bound hardcover to a place with a folded corner, and saw a series of conspicuous work units and names behind a person's name.

This is the case with the names on the entire page.

"Good guy, you don't have to queue up when you fly." Yang Rui sighed.

Huang Mao rolled his eyelids, but he couldn't say that Yang Rui was wrong.

"What should we do now?" Huang Mao asked: "Some people have called, I answered two, and quickly unplugged the phone, didn't you receive the call?"

Yang Rui was stunned for a moment, and said, "I haven't been in the clinical trial center for the past two days."

Jingle Bell.

Just as he was talking, the phone that he had just hung up rang again.

Yang Rui hesitated for a moment, but still picked it up, hummed twice, and said, "I understand what Mr. Li said, and like this, I'll ask Huang Mao to see what his arrangement is."

After speaking, Yang Rui hung up the phone and unplugged the phone line decisively.

Huang Mao stared at Yang Rui with piercing eyes.

Yang Rui shrugged, pointed to the thick booklet, and said, "This guy is bigger than everyone in the book."

"Then... what should we do?" Huang Mao was also helpless: "It's really not possible, let's arrange it?"

"Are you kidding? If something goes wrong, you will be a rare massacre in the world." Yang Rui vetoed it with one word. The so-called human life is at stake. Although he knows that sildenafil is fine, what is the loophole in the incomplete guarantee?

As a scholar, even if it succeeds, it is still a joke to do the second phase clinical trial with a scale of tens of thousands of people.

"If this doesn't work, let's apply for the Provincial Drug Approval at the same time." Before Huang Mao came to find Yang Rui, he had already thought about it.

...

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