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

"Oh, Huang Mao, what's wrong?" Yang Rui rubbed his temples, still immersed in the tiredness of constant phone communication.

Changing the test items of a new drug is not a simple matter. Many new drugs will try to add new indications after they start selling, but if a new drug has not passed clinical trials and wants to change the indication, it is tantamount to failure.

The FDA will only be harsher on new drugs that fail to be reviewed.

More often than not, it is not passed.

Historically, Pfizer also took a lot of effort to change the indication of sildenafil, which took more than half a year and an indescribable price to make the FDA relent.

Compared with Pfizer, the largest pharmaceutical company in the United States, Greenstone Point, which cooperates with Sinovel, is just a small guy, its scale is less than one-tenth of Pfizer's, and the government relationship is as weak as a dog, and the lobbyist company that has been cooperating for a long time can influence less than 30 members of Congress, and it lacks hardcore supporters, and its public relations funds and industry power 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 for the world's three major journals to publish Science, and if a scholar from any country wants to publish an article in Science at any time, if he does not rely on luck, he can only hold back his big moves.

A scholar assumes that he starts to do experiments at the age of 40 to accumulate data, and when he is 50 years old, the data he has saved is only eligible to be submitted to Science, and whether he can publish it or not is a different matter.

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

And the number of submissions per year, from a paper perspective, is also an astronomical number.

The chances of successfully publishing only 100 articles a year are so low that most scholars regard them as good luck.

is also Yang Rui, so that he can press and hold the G spot of "science" if he wants to.

The title of Nobel laureate is only one aspect – but it must also be said that it is very useful, especially for young and active Nobel laureates, whose articles are bound to be extremely valued from the moment they fall into the hands of editors.

The specificity of sildenafil, especially the prevalence of nitric oxide-related topics, has led to increased recognition.

If there were no additional changes, nitric oxide would have been named Molecule of the Year by Science in '92.

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

Any relevant research will be looked down upon in any journal.

Not to mention the nitric oxide compounds brought by the Nobel laureates.

The reason why sildenafil can harden the corpora cavernosa is that it stimulates the body and releases nitric oxide.

From this point of view, 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 yet, and they don't need to, if they want to make Science do what they want.

Sildenafil was only a useful compound screened out by a commercial company, and it sold for $180 million, but in the eyes of the scientific community, it may not have the weight of "being favored by Yang Rui".

The chemists responsible for conducting clinical experiments on sildenafil are just fourth-rate scientists in the world - first-rate Nobel Prize, second-rate Nobel Prize, third-rate lectures at prestigious universities, fourth-rate tenured professors - fourth-rate scientists are certainly world-class in the eyes of the public, but "Science" has never been in the eyes of the public.

However, when Comrade Yang Rui, the world's first-order scientist, analyzed sildenafil in its entirety and made a new description from the viewpoint of nitric oxide theory, "Science" had to give way.

For example, Chaoben like Yang Rui is publishing a review of nitric oxide, and "Science" will publish it if he can't get it, let alone a paper with complete data and novel ideas.

The most important thing about the paper is actually the idea.

When it comes time to study for a Ph.D., how can a good student be distinguished between a good student? Does it depend on who kills a rat and kills a wonderful person? It is nothing more than whose thinking is brilliant and who is powerful.

Scholars and professors are the same for scientists, there are scientific research dogs doing the work, and the workload is nothing more than using a few more scientific research dogs, spending a few more 1200 per month, and the division of classes ultimately depends on the idea.

And when Yang Rui needs to come up with subtle ideas, it's not that he is not modest, everyone else is scum.

Science magazine was also instantly seconded.

Several reviewers contacted the editor as soon as possible, gave a review of the article, and vigorously recommended it - the double anonymity system of 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-level scholars, the resources of high-end scholars themselves are enough to break through this barrier.

For example, the word "sildenafil", as long as it appears in the paper, everyone can think of Yang Rui for the first time.

The news that he spent 180 million to buy Pfizer was not hidden, and anyone who cares about the scientific community can more or less hear some rumors, and the relevant circles are even more so. Besides, the review is not a closed-book exam, and the reviewer also needs reference materials, no matter what posture is used to check it, it is impossible to miss Yang Rui's news.

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

The whole process, Yang Rui didn't have to take the initiative to promote, 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.

To say that the FDA, for pharmaceutical companies, is indeed a god-like existence, life and death are not exaggerated, especially after the 80s, the authority of the FDA can be said to be extremely powerful.

However, the FDA is not immune.

Its lifeblood is science.

The independence and authority of the FDA is based on science, and most of the scientists who serve it are well-known experts in the industry.

Although these people can stick to their own opinions and make decisions, just like Yang Rui did with Lu Boding that day, but when faced with scientific problems, their independence has to be shaken.

The scientific questions raised by ordinary scholars are, of course, unshakeable to the experts of the FDA.

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

Bureaucrats 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 have hired Nobel laureates since the 90s, but the reality is that few pharmaceutical companies can really hire Nobel laureates who are active in scientific research.

The Nobel Prize in Medicine and Physiology is awarded to a maximum of three people a year, many of whom are still awarded to old men.

Young and middle-aged scholars have a low chance of winning the Nobel Prize, and it is really rare for them to give up scientific research and go to pharmaceutical companies.

is Yang Rui, doing sildenafil is also a state of odd jobs - if it weren't for the amazing profits of viagra, he could save himself time and make money, increase scientific research funds, change a drug, and Yang Rui would not have been able to do so much after winning the Nobel Prize.

For the world's first-order 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 - in any case, they take money according to the proportion of GDP.

The request for sildenafil to change its indication has been approved by the FDA faster than in history - "Science" has been published, 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 is very laborious, and for Huang Mao, who is presiding over the clinical trial, it is pressure.

"Professor, this is the list of volunteers for the second phase of the clinical trial. Huang Mao lowered his head and put a thick notebook on the table, making a banging sound.

Yang Rui glanced at it, and his eyebrows furrowed: "You made a mistake." ”

But no, the thick hardcover book of the thread is all used to write names......

"There were twenty-seven thousand four hundred and twenty-seven in all. Huang Mao said: "Obviously unsuitable volunteers have been eliminated. ”

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

"That's more. Huang Mao couldn't help but complain: "I checked the literature, this kind of clinical experiment in foreign countries is generally signed up by hundreds of people, and many are recommended by doctors." ”

The recommendation of a licensed physician is very important for the clinical trials of pharmaceutical companies, especially for the phase II experiments, where the safety issue has not been completely solved, and there is no trusted doctor to tell you that this is the most appropriate choice.

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

"I guess I know. Huang Mao paused for a moment and said: "The question is not how many of them there are, I can also select them if there are many people, you look at the identities of these people." ”

Huang Mao opened the hardcover book to a place with folded corners, and saw a string of conspicuous work units and names written behind a person's name.

That's the name for a whole page.

"Good guys, you don't have to wait in line when you fly. Yang Rui sighed.

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

"What now?" Huang Mao asked: "Some people have called, I answered two, and quickly pulled out 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 bells.

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, and said twice, "I understand what Mr. Li said, in this case, I'll ask Huang Mao to see what kind of arrangement he has over there." ”

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

Huang Mao stared at Yang Rui with bright little eyes.

Yang Rui shrugged, pointed to the thick booklet, and said, "This is a big name compared to the people in the book." ”

"That'...... What should I do?" Huang Mao was also helpless: "It's really not good, let's arrange it?"

"What are you kidding, if something goes wrong, you're a rare massacre in the world. Yang Rui vetoed. The so-called human life is at stake, although he knows that Xidi is fine, what are the loopholes in the middle?

As a scholar, doing a phase II clinical trial with a scale of tens of thousands of people, even if it is successful, it is a joke.

"If this doesn't work, let's apply for the provincial drug approval word at the same time. "Before Huang Mao came to Yang Rui, he had already thought about it.

……

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