Chapter 508: You've Changed!
Wang Xin is Chinese, and when he was in college, he received an admission letter from New York University, and if it weren't for the full scholarship, he wouldn't have come.
Coming to a strange country and city is not a good thing for an introverted boy, especially his English, which is limited to written and spoken English...... Some are average.
The annual A+ does not bring him much joy, and if he can, he hopes to complete the project and return to China as soon as possible.
Among this group of people who came to SPOM to participate in internships and projects, Wang Xin was the hardest-working, but also the most unpleasant, not for why, because of his withdrawn personality.
When everyone looked at him, Wang Xin nervously organized his language and said: "In fact, when submitting an application to the FDA, if any item wants to pass the approval of the US Food and Drug Administration, it must submit the detailed information of the product, including the chemical molecular equation of the substance...... If you can get the sample, why don't you just ask for the chemical molecular equation?"
Everyone was stunned and silent!
looked at each other, and there was a feeling of eating Xiang.
They are all testing the parameters of the product, or they want to get the product breakdown structure, but they haven't thought of taking the chemical equation?
Fairman's old face turned red and he asked directly, "What's your name? Is it a staff member?"
Wang Xin shrugged: "Wang Xin." Graduate Student Intern at New York University. ”
Fellman suddenly smiled: "I will write your internship report myself, I can tell you a good news in advance, your internship results, full marks, if you want to come to SPOM after graduation, I welcome you." ”
Wang Xin continued to shrug his shoulders: "It's an honor. ”
In my heart, I smiled, a group of brain-dead ......
Now he really wants to return to China as soon as possible, get his graduation certificate and degree certificate, and bring his research results, it is best to meet that Bai Ye.
His curiosity about Bai Ye is getting stronger and stronger now, because he was present at the whole test, so he naturally understands the significance of this product.
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The next day, Mark Norman got his wish and got the equation for the chemical molecule.
However, the only thing that hasn't changed is that the people around me are looking at the model molecular equations with a confused face!
Such a molecular structure is unbelievable!
If yesterday a group of people were stupid to death!
Today they feel like they are suffocating.
Because...... They have nowhere to start, and according to their previous understanding of the material, if this substance can react normally in the human body, it is absolutely safe, decomposing into carbon dioxide, nitrogen dioxide, water and other metabolites.
In fact, to put it bluntly, yesterday was unclear whether it was dead, and today it is clear and clear.
It's such a thing, the chemical equations are all given to you, clear, clear, but you just don't know how to get him.
It's like giving you an iron lump, and you can't start it.
However, SPOM will not give up so easily, so they have invested a lot of manpower and material resources in it, and set up a special research team, hoping to find and find out what is so awesome about this substance.
And the same is true of the US FDA, their researchers have tested it and found that this kind of thinking and creativity is really constructive, and even said that Bai Ye's inspiration gave these people a chance.
In particular, the Fino Group seems to have found a way to be reborn!
That is, to find a new substance, to replace it, and to re-study a new type of substance that can cover the surface of cobalt-chrome alloys.
And the US FDA naturally stuck Bai Ye's product, and in a short period of time, it did not plan to let him pass until a new substance was found.
Since you are indeed ahead of us, then I will block you and prevent you from going public, and take this opportunity to let your own forces conduct research.
Time passes slowly......
Ten days later, on November 3, the US FDA gave an accurate answer to the Bai Ye Institute that submitted the application!
"Identified by experts and professors from the FDA Testing Center of our country, it is believed that the substances provided by the research institute are effective and the product safety is good, but there is a lack of international clinical trial results, and a unified model has not been established in the data, because of the promulgation of the new FDA standards, in order to strengthen unified management, I hope that the institute can conduct phase III clinical trials in China's domestic research institute, and after the results are obtained, it will be allowed to be marketed!"
This news directly made Bai Ye sneer.
What does this news mean?
That is to say, your product is very good, and the safety is okay, but what about it, you use the same phase III clinical trial standard in China or the world, but it is not used by us Americans, so if you want to be marketed in the United States, and you want to get permission from the US FDA, you come to us to do a phase III clinical trial again.
This is equivalent to telling the Chinese diplomatic department, I will give you face, omit the first and second phases, and directly let you do the third phase, and also admit that the product is effective.
Well, if the development goes well, it is estimated that it will be successfully carried out in more than half a year.
And the other party's excuse is also very good, such a big thing happened in the United States last year, and it was Bai Ye who made it, so our FDA standards should be reset, and you should come to us to do the third phase of the experiment.
You don't care about SPOM listing, you take care of us!
This is clearly hanging you!
I don't give you a listing in the United States.
As long as it does not pass the FDA standard, it means that it is difficult to enter the international market, because many countries around the world use the US FDA standard.
However, this time, Bai Ye and their preparations were very thorough!
November 5th!
Will Tong, Secretary-General of the World Health Organization, made his remarks official.
After the research results of the World Health Organization and the Billy Institute in Switzerland, the new PLA material developed by the Baiye Research Institute combined with cobalt-chromium alloy prosthesis has good safety and excellent physical and chemical properties, which is fully in line with the human prosthesis means!
On the same day, Switzerland announced that the new materials submitted by the Bai Ye Institute had been inspected by the domestic security department and allowed to enter Switzerland.
The German food and drug regulatory department announced: It is hoped that the Baiye Research Institute will build a factory in Germany and provide prostheses as soon as possible.
On this day, many EU countries directly expressed their positions, and the new products submitted by Bai Ye have passed the inspection and are welcome to be listed at any time!
Then, the United Kingdom, Russia, South Africa, Italy, France, Sydney, Singapore...... They have expressed that they welcome the launch of Bai Ye's new products!
Lao Mei, who was about to watch the Chinese joke, suddenly fell silent.
Parorila is full of frustration and anger: the older you get, the more cunning you become...... Cards that don't follow common sense!