Wang Xin is Chinese. When he was in college, he received an admission notice from New York University. If it were not for the full scholarship, he would not have come.
Coming to a strange country and city was not a good thing for an introverted boy, especially since his English was limited to written and spoken... somewhat average.
A+ every year does not bring him much happiness. If possible, 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 least lovable. For no reason, just because of his withdrawn personality.
When everyone looked at him, Wang Xin nervously organized his words and said: "Actually, when submitting an application to the FDA, any item that wants to be approved by the U.S. Food and Drug Administration must submit product documentation.
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, they actually felt like they had eaten 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 getting a chemical equation?
Fairman blushed and asked directly: "What's your name? Are you a staff member? Which group do you belong to?"
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 good news in advance. Your internship results are full marks. If you want to come to SPOM after graduation, I will welcome you."
Wang Xin continued to shrug: "It's an honor."
In my heart, I was laughing, a bunch of idiots...
Now he really wants to return to China as soon as possible, get his graduation certificate and degree certificate, and bring his research results with him. It would be best to meet Bai Ye.
He is now more and more curious about Bai Ye. Because he was present during the entire inspection, he naturally understands the significance of this product.
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The next day, Mark Norman got his wish and obtained the chemical molecular equation.
However, the only thing that has not changed is that the people around me are looking at the model molecular equation with confused expressions!
Such a molecular structure is incredible!
What if a group of people were so stupid yesterday!
Today they feel like they are suffocated to death.
Because... they have nowhere to start. According to their past understanding of materials, if this substance can react normally in the human body, it is absolutely safe and decomposes into carbon dioxide, nitrogen dioxide, water and other metabolic substances.
In fact, to put it bluntly, yesterday it was unclear whether he was dead, but today he is clearly confused.
It's just such a thing. The chemical equation is given to you, clearly and clearly, but you just don't know how to do it.
It's like giving you an iron block, and you feel like you can't do anything.
However, spom 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 tested it and found that this idea and creativity is really constructive. They even said that Bai Ye's inspiration gave these people a chance.
Especially the Feinuo Group seems to have found a way to be reborn!
That is to find a new substance to replace it, and to re-research a new substance that can cover the surface of cobalt-chromium alloy.
The US FDA has naturally blocked Bai Ye's product, and has no plans to let it pass for a short period of time until a new substance is found.
Since you are indeed ahead of us, then I will block you and prevent you from going public. I will use this opportunity to conduct research with my own power.
Time passes slowly...
Ten days later, on November 3rd, the US FDA gave an accurate answer to the Baiye Institute that submitted the application!
"After appraisal by experts and professors from our National FDA Testing Center, it is believed that the substances provided by this institute are effective and the products are safe. However, 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, in order to
To strengthen unified management, we hope that the research institute can conduct the third phase clinical trial within the designated research institute in our country, and after the results are obtained, it will be allowed to be put on the market!"
This news directly made Bai Ye sneer.
What does this news mean?
That is to say, your product is very good and safe, but you use the same phase III clinical trial standards in China or in the world, but they are not used by us Americans. Therefore, you want to use them in the United States.
If you want to get approval from the U.S. FDA before going on the market, you come to us to conduct the third phase of clinical trials again.
This is equivalent to telling the Chinese foreign affairs department that I will give you face by skipping 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 smoothly, it is estimated that it will be successfully launched 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. Therefore, our FDA standards should be re-set. You should come to us for the third phase of experiments.
If you don't care about spom listing, you can care about us!
This is obviously to keep you busy!
We won't let you list it in the United States.
As long as it does not pass FDA standards, it means that it is difficult to enter the international market, because many countries in the world use US FDA standards.
However, this time, Bai Ye and the others were very well prepared!
November 5th!
Will Tang, Secretary-General of the World Health Organization, made a formal statement.
The research results of the World Health Organization and the Swiss Billy Research Institute have proven that the new pla material developed by Baiye Research Institute combined with cobalt-chromium alloy prostheses has good safety, excellent physical and chemical properties, and is completely in line with human body prostheses!
On the same day, Switzerland announced that the new materials submitted by the Baiye Institute had passed inspection by the domestic security department and were allowed to enter Switzerland.
The German Food and Drug Administration announced that it hopes the Baiye Institute will build a factory in Germany and provide prostheses as soon as possible.
On this day, many EU countries expressed their positions directly. The new product submitted by Bai Ye has passed the inspection and is welcome to be launched at any time!
Then, the United Kingdom, Russia, South Africa, Italy, France, Sydney, Singapore... all expressed their welcome to the launch of Baiye's new products!
The old American who was about to read a Chinese joke suddenly fell silent.
Parolila was full of helplessness and anger: The older you get, the more cunning you become...you don't play according to common sense!