Chapter 1499 Dial the phone
"Professor." Huang Mao knocked on the door and entered Yang Rui's office.
"Oh, Huang Mao, is there something wrong?" Yang Rui rubbed his temples, immersed in the fatigue of continuous telephone communication.
Replacing a test program for a new drug is not an easy task. Many new drugs will try to add new indications after they start selling. However, if a new drug wants to change the indication before passing the clinical trial, it is equivalent to a failure.
The FDA will only be more demanding when dealing with new drugs that fail to retrial.
Most of the time, it is not approved.
Historically, Pfizer has taken a lot of effort to replace the indications of sildenafil, and it took more than half a year and an indescribable price to make the FDA feel relieved.
Compared with Pfizer, the largest pharmaceutical company in the United States, Green Stone Corner, which cooperates with Huarui, is just a little guy. Its scale is less than one-tenth of Pfizer, and its government relations are as weak as a dog. The lobbyist company that has long-term cooperation can influence less than 30 members of Congress, and it lacks hard-core supporters. 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 called "Science".
Indeed, "Science" in the world's three major journals is difficult to publish. If scholars from any country at any time want to publish an article to "Science", if they do not rely on luck, they can only hold their ultimate moves.
A scholar assumes that he starts experimenting with data-storing skills from the age of 40, and he saves until he is 50, and the data he saves is only qualified to submit "Science". Whether it can be published is still a different matter.
"Science" is a targeted at all fields. Everything in the field of science, from traditional physics and chemistry, popular computer hardware and software, rare paleontology excavation and Egyptian writing research, is qualified. It is the most extensive in CNS. It can be said that except for pure liberal arts projects involving liberal arts monks, anyone has the hope of publishing "Science".
The number of contributions per year, from the perspective of the paper, is also an astronomical number.
Those who are lucky enough to publish successfully can only be a hundred articles a year. The probability is too low, so most scholars regard it as good luck.
Only Yang Rui can hold down the G-spot of "Science" and hold it down.
The title of Nobel Prize winner is only one aspect - but it has to be said that its role is very great, especially the young and active Nobel Prize winners. Its articles must be taken seriously from the moment they fall into the hands of the editor.
The particularity of sildenafil, especially the popularity of nitric oxide-related topics, has brought more recognition.
If there is no additional change, by 1992, nitric oxide will be rated as the Molecule of the Year by Science.
In recent years, the issue of nitric oxide has become too popular.
Any related research will be highly regarded in any journal.
Not to mention the nitric oxide compounds brought by Nobel Prize winners.
The reason why sildenafil can harden the cavernosum is that it stimulates the body and releases nitric oxide.
From this perspective, eating Viagra is to inflate yourself.
What "science" wants to publish is the inflatable process.
Pfizer may be very awesome in the business field, but it is not necessary for them to follow the rules of Science.
Sildenafil was just a useful compound screened out by a commercial company. It sold for $180 million, but in the eyes of the scientific community, it may not be as heavy as "being attracted by Yang Rui".
The chemist responsible for clinical experiments on sildenafil is just a world-class scientist - first-class winners, second-class winners, third-class winners, and third-class professors, and fourth-class scientists are world-class scientists, although in the eyes of the public, "Science" has never been seen by the public.
However, when Comrade Yang Rui, the world's first-rank scientist, analyzed the entire sildenafil and made a new description based on the perspective of nitric oxide theory, "Science" had to give way.
For a super-ben like Yang Rui, he just published a review of nitric oxide. If Science is not done well, it will be published, let alone a paper with complete data and novel ideas.
The most important thing about the thesis is actually the idea.
When it comes to studying for a doctorate, how can we distinguish good students from students? Can we see who kills rats and kills them so well? It’s just whose thinking is so brilliant.
The same goes for scholars, professors and scientists. All work is done by scientific research dogs. The workload is large, just to use more scientific research dogs, spend more than 1,200 yuan a month. The division of classes ultimately depends on the idea.
When Yang Rui needed to put forward exquisite ideas, it was not that he was not humble, but that everyone else was a scumbag.
The magazine Science was also instantly instantly.
Several reviewers contacted the editor as soon as possible, gave the evaluation of the article, and strongly recommended it - the dual anonymous system of scientific research papers is useless in the high-end scholar group.
Not to mention whether the journal itself can firmly abide by Nobel Prize-level scholars, the resources of high-end scholars themselves are enough to break through this barrier.
For example, the term "sildenafil" will appear in the paper and you will think of Yang Rui as soon as it appears.
The news that he spent 180 million to buy Pfizer was not hidden. Anyone who cares about the scientific community can hear more or less the news, and the relevant circles are even more so. Besides, reviewers are not a closed-book exam, and reviewers also need reference materials. No matter what posture they use to check, they cannot miss Yang Rui's news.
The news that "Yang Rui has made new achievements" was spread before the latest issue of "Science" was published, and the forced "Science" had to schedule it at the fastest speed.
Yang Rui did not have to take the initiative to push the whole process, and it was completed easily.
When the people from Green Stone Corner took "Science" to the FDA, the FDA scientists actually received the news.
To talk about FDA, for pharmaceutical companies, it is indeed a god-like existence, and it is not an exaggeration to seize life and death, especially after the 1980s, the authority of the FDA can be said to be extremely powerful.
However, the FDA is not inseparable from water and fire.
Its life gate is science.
The independence and authority of the FDA are based on science, and the scientists who serve it are mostly famous experts in the industry.
Although these people can make decisions with their own opinions, just like Yang Rui made a custom-made decision for Lu Bo that day, their independence had to be shaken when facing scientific problems.
The scientific questions raised by ordinary scholars certainly cannot shake FDA experts.
However, if they remain indifferent to the demands of the Nobel Prize winners and scholar Yang Rui, who is in the active stage of scientific research, their fame and independence will be greatly reduced.
Bureaucrats and procrastination are not allowed when replying to 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 Prize winners after the 1990s. However, the reality is that few pharmaceutical companies can really hire Nobel Prize winners in the active period of scientific research.
The Nobel Prize in Medicine and Physiology is given to at most three people every year, and many of them are given to the old man.
Young and middle-aged scholars have low chances of winning the Nobel Prize, and it is rare for those who are willing to give up scientific research and go to pharmaceutical companies.
Even Yang Rui, doing sildenafil is also a odd job. If it weren't for Viagra's amazing profits, he could save time and earn money and increase scientific research funds and change to another medicine, Yang Rui wouldn't have done his best after winning the Nobel Prize.
For the world's first-class scientists, time is the most important resource, and money is no longer important.
Instead of 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.
The requirement for changing indications of sildenafil has passed the FDA approval faster than in history, and it still takes courage to come against the mainstream scientific community.
This time, the FDA did not show it.
For Yang Rui, the whole thing was very difficult, but for Huang Mao, who was in charge of the clinical experiment, it was a pressure.
"Professor, this is the list of volunteers for the second phase of clinical practice." Huang Mao lowered his head and placed a thick notebook on the table, making a thud sound.
Yang Rui glanced at it, and his eyebrows frowned: "You've got the wrong book."
No, the hard-skinned and thick-skinned book is all used to write names...
"There are 27,427 people in total." Huang Mao said: "The obviously inappropriate volunteers have been eliminated."
"27427 people, there are a lot of people..." Yang Rui guessed that many people would come to sign up, but he didn't expect that there would be so many people.
"It's more than just a lot." Huang Mao couldn't help but complain: "I checked the literature. Such clinical experiments abroad usually only require hundreds of people to register, and most of them are recommended by doctors."
The recommendation of a practicing physician is very important for the clinical experiments of pharmaceutical companies, especially the second phase of the experiment. The safety problem has not been completely solved. Doctors without trust tell you that this is the most appropriate choice. Under the premise of knowing that this is the small number of people, let alone registering.
"Do they know the meaning of phase 2 clinical practice?" Yang Rui couldn't help but say: "We just made a mistake before. Do they know the dangers?"
"I probably know." Huang Mao paused and said, "The problem is not how many people they have. I can select them even if there are too many people. Look at the identities of these people."
Huang Mao opened the thread-mounted hard-crust notebook to a place with a corner, and saw a series of conspicuous work units and names behind a person's name.
The names of a whole page are like this.
"Good guys, 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 I do now?" Huang Mao asked: "Some people have called. I answered two of them and quickly unplugged them. Didn't you receive the call?"
Yang Rui was stunned for a moment and said, "I have not been in the clinical experimental center these two days."
Dingling.
As he was talking, the phone that had just hung up rang again.
Yang Rui hesitated for a moment, but he still answered, and said, "I understand what Mr. Li said. In this way, I will ask Huang Mao to see what arrangements he has made."
After saying that, Yang Rui hung up the phone and decisively unplugged the phone line.
Huang Mao stared at Yang Rui with his bright little eyes.
Yang Rui shrugged, pointed to the thick booklet, and said, "This person in the book is a big name."
"Then...what should we do?" Huang Mao was helpless: "If it really doesn't work, let's arrange it all?"
"What a joke? If something goes wrong, you will be a rare massacre in the world." Yang Rui vetoed it. The so-called life is at stake. Although he knew that sildenafil was fine, he could not guarantee any loopholes in the middle?
As a scholar, if you do the second phase clinical trial, it will be a joke even if you succeed.
"If this doesn't work, let's apply for the drug-saving word at the same time." Huang Mao had already thought about it before he came to Yang Rui.
...
Chapter completed!