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Chapter 489 You——Changed!
Chapter 489 You——Changed!
Wang Xin is Chinese. He received an admission letter from New York University when he was in college. If it wasn't for the full scholarship, he would not have come.
For an introverted boy, it was not a good thing for him to come to a strange country and city, especially his English, which was limited to written, spoken English...somewhat average.
A+ every year does not bring him too much happiness. If possible, he hopes to finish the project and return to China as soon as possible.
Among the group of people who came to SPOM to participate in internships and projects, Wang Xin is the hardest, but also the least lovable, not because of his withdrawn personality.
When everyone looked at him, Wang Xin organized his language nervously, and said: "Actually, when submitting an application to the FDA, any item that wants to pass the approval of the US Food and Drug Administration must submit a product certificate." Detailed information, including the chemical molecular equation of the substance, I... Since you can get the sample, why don't you just ask for the chemical molecular equation?"
Everyone was stunned and fell silent!
Looking at each other, there was a feeling of eating Xiang.
They are all testing the parameters of the product, or want to get the decomposition structure of the product, but have they never thought of taking the chemical equation?
Fairman blushed and asked directly: "What's your name? Are you a staff member? Which group?"
Wang Xin shrugged: "Wang Xin, an intern graduate student at New York University."
Fellman suddenly smiled: "I will write your internship report myself, and I can tell you a good news in advance, your internship results are full marks, if you come to SPOM after graduation, I welcome it."
Wang Xin continued to shrug his shoulders: "I'm extremely honored."
He laughed in his heart, a group of brain-dead...
Now he really wants to return to China as soon as possible, get his graduation certificate and degree certificate, bring his own research results, and it would be best if he could meet that Bai Ye.
Now his curiosity about Bai Ye became more and more intense, because he was present for the whole test, so he naturally understood the significance of this product.
........................
........................
The next day, Mark Norman got the chemical molecular equation as he wished.
However, the only thing that hasn't changed is that the people around are looking at the model molecular equation with bewildered expressions!
Such a molecular structure is unbelievable!
If a group of people were stupid yesterday!
Today they feel like they are suffocated.
Because...they have nowhere to start. According to their previous understanding of materials, if this substance can react normally in the human body, it is absolutely safe. It is decomposed into carbon dioxide, nitrogen dioxide, water and other metabolic substances.
In fact, to put it bluntly, he was dead and unclear yesterday, but today he is ignorant and clear.
It’s just such a thing, the chemical equations are all given to you, clearly and clearly, but you just don’t know how to deal with it.
It's like giving you an iron lump, and you can't do anything anyway.
However, SPOM naturally will not give up so easily. For this reason, they have invested a lot of manpower and material resources in it, and set up a special research team, hoping to discover and find out what is so awesome about this substance.
The same is true for the US FDA. Their researchers have been tested and found that this idea and creativity are really constructive. They even said that Bai Ye's inspiration gave these people a chance.
Especially the Fei Nuo Group, it seems that they have found a way to be reborn!
That is to find a new substance to replace it, and re-research a new type of substance that can cover the surface of the cobalt-chromium alloy.
However, the FDA of the United States naturally blocked Bai Ye's product, and did not plan to allow him to pass it in a short time until it found a new substance.
Since you are indeed ahead of us, then I will block you and prevent you from going public. I will take this opportunity to let myself do research.
Time goes by slowly...
Ten days later, on November [-]rd, the US FDA gave an accurate answer to the Bai Ye Research Institute that submitted the application!
"Identified by the experts and professors of the FDA Testing Center in China, it is believed that the substances provided by the 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 on the data. Because of the promulgation of new FDA standards, for To strengthen unified management, I hope that the research institute can conduct the third phase of clinical trials in the research institute in our country, and after the results are obtained, it will be allowed to go on the market!"
This news directly made Bai Ye sneer.
What does this message mean?
That is to say, your product is quite good and safe, but you are using the same phase III clinical trial standard in China or in the world, but it is not used by us Americans, so you want to use it in the United States. To go on the market, if you want to get the approval of the US FDA, you come to us to do the third phase clinical trial again.
Well, if the development goes well, it is estimated that it can be successfully carried out in more than half a year.
And the other party’s excuse is also very good, Bai Ye was responsible for such a big incident in the United States last year, so our FDA standards should be re-set, you should come to us for the third phase of the experiment.
You don't care about the listing of SPOM, you care about us!
This is clearly leaving you alone!
You will not be listed 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 in the world use the US FDA standard.
However, this time, Bai Ye and the others were fully prepared!
November fifth!
The Secretary-General of the World Health Organization, Will Tong, made a formal statement.
The research results of the World Health Organization and the Swiss Billy Institute have proved that the new PLA material developed by the Baiye Institute combined with the cobalt-chromium alloy prosthesis has good safety and excellent physical and chemical properties, which is completely in line with the means of human prosthesis!
On the same day, Switzerland announced that the new material submitted by the Bai Ye Research Institute had passed the inspection of the domestic security department and was allowed to enter Switzerland.
The German Food and Drug Administration announced that it hopes that the Bai Ye Research Institute will build a factory in Germany and provide prostheses as soon as possible.
And on this day, many EU countries directly expressed their positions. The new product submitted by Bai Ye has passed the inspection, and it is welcome to launch at any time!
Then, the United Kingdom, Russia, South Africa, Italy, France, Sydney, Singapore... all expressed their welcome to the launch of Bai Ye's new products!
Palo Lila is full of helplessness and anger: You are getting older and more cunning... Play your cards out of common sense!
(End of this chapter)
Wang Xin is Chinese. He received an admission letter from New York University when he was in college. If it wasn't for the full scholarship, he would not have come.
For an introverted boy, it was not a good thing for him to come to a strange country and city, especially his English, which was limited to written, spoken English...somewhat average.
A+ every year does not bring him too much happiness. If possible, he hopes to finish the project and return to China as soon as possible.
Among the group of people who came to SPOM to participate in internships and projects, Wang Xin is the hardest, but also the least lovable, not because of his withdrawn personality.
When everyone looked at him, Wang Xin organized his language nervously, and said: "Actually, when submitting an application to the FDA, any item that wants to pass the approval of the US Food and Drug Administration must submit a product certificate." Detailed information, including the chemical molecular equation of the substance, I... Since you can get the sample, why don't you just ask for the chemical molecular equation?"
Everyone was stunned and fell silent!
Looking at each other, there was a feeling of eating Xiang.
They are all testing the parameters of the product, or want to get the decomposition structure of the product, but have they never thought of taking the chemical equation?
Fairman blushed and asked directly: "What's your name? Are you a staff member? Which group?"
Wang Xin shrugged: "Wang Xin, an intern graduate student at New York University."
Fellman suddenly smiled: "I will write your internship report myself, and I can tell you a good news in advance, your internship results are full marks, if you come to SPOM after graduation, I welcome it."
Wang Xin continued to shrug his shoulders: "I'm extremely honored."
He laughed in his heart, a group of brain-dead...
Now he really wants to return to China as soon as possible, get his graduation certificate and degree certificate, bring his own research results, and it would be best if he could meet that Bai Ye.
Now his curiosity about Bai Ye became more and more intense, because he was present for the whole test, so he naturally understood the significance of this product.
........................
........................
The next day, Mark Norman got the chemical molecular equation as he wished.
However, the only thing that hasn't changed is that the people around are looking at the model molecular equation with bewildered expressions!
Such a molecular structure is unbelievable!
If a group of people were stupid yesterday!
Today they feel like they are suffocated.
Because...they have nowhere to start. According to their previous understanding of materials, if this substance can react normally in the human body, it is absolutely safe. It is decomposed into carbon dioxide, nitrogen dioxide, water and other metabolic substances.
In fact, to put it bluntly, he was dead and unclear yesterday, but today he is ignorant and clear.
It’s just such a thing, the chemical equations are all given to you, clearly and clearly, but you just don’t know how to deal with it.
It's like giving you an iron lump, and you can't do anything anyway.
However, SPOM naturally will not give up so easily. For this reason, they have invested a lot of manpower and material resources in it, and set up a special research team, hoping to discover and find out what is so awesome about this substance.
The same is true for the US FDA. Their researchers have been tested and found that this idea and creativity are really constructive. They even said that Bai Ye's inspiration gave these people a chance.
Especially the Fei Nuo Group, it seems that they have found a way to be reborn!
That is to find a new substance to replace it, and re-research a new type of substance that can cover the surface of the cobalt-chromium alloy.
However, the FDA of the United States naturally blocked Bai Ye's product, and did not plan to allow him to pass it in a short time until it found a new substance.
Since you are indeed ahead of us, then I will block you and prevent you from going public. I will take this opportunity to let myself do research.
Time goes by slowly...
Ten days later, on November [-]rd, the US FDA gave an accurate answer to the Bai Ye Research Institute that submitted the application!
"Identified by the experts and professors of the FDA Testing Center in China, it is believed that the substances provided by the 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 on the data. Because of the promulgation of new FDA standards, for To strengthen unified management, I hope that the research institute can conduct the third phase of clinical trials in the research institute in our country, and after the results are obtained, it will be allowed to go on the market!"
This news directly made Bai Ye sneer.
What does this message mean?
That is to say, your product is quite good and safe, but you are using the same phase III clinical trial standard in China or in the world, but it is not used by us Americans, so you want to use it in the United States. To go on the market, if you want to get the approval of the US FDA, you come to us to do the third phase clinical trial again.
Well, if the development goes well, it is estimated that it can be successfully carried out in more than half a year.
And the other party’s excuse is also very good, Bai Ye was responsible for such a big incident in the United States last year, so our FDA standards should be re-set, you should come to us for the third phase of the experiment.
You don't care about the listing of SPOM, you care about us!
This is clearly leaving you alone!
You will not be listed 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 in the world use the US FDA standard.
However, this time, Bai Ye and the others were fully prepared!
November fifth!
The Secretary-General of the World Health Organization, Will Tong, made a formal statement.
The research results of the World Health Organization and the Swiss Billy Institute have proved that the new PLA material developed by the Baiye Institute combined with the cobalt-chromium alloy prosthesis has good safety and excellent physical and chemical properties, which is completely in line with the means of human prosthesis!
On the same day, Switzerland announced that the new material submitted by the Bai Ye Research Institute had passed the inspection of the domestic security department and was allowed to enter Switzerland.
The German Food and Drug Administration announced that it hopes that the Bai Ye Research Institute will build a factory in Germany and provide prostheses as soon as possible.
And on this day, many EU countries directly expressed their positions. The new product submitted by Bai Ye has passed the inspection, and it is welcome to launch at any time!
Then, the United Kingdom, Russia, South Africa, Italy, France, Sydney, Singapore... all expressed their welcome to the launch of Bai Ye's new products!
Palo Lila is full of helplessness and anger: You are getting older and more cunning... Play your cards out of common sense!
(End of this chapter)
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