Chapter 905: Do you want me to do a repeat experiment?
Also unexpected by Yang Rui was the tenacity of Qin Hanchi and his party.
Lao Yan blocked them at the door, and the three of them didn't even leave, and finally waited for the end of the ion channel laboratory.
Yang Rui rode his bicycle and went out, looking at the three people, he was also a little helpless.
He really hasn't met this kind of plaster-like character, of course, I heard that he has heard a lot, and now the country's triangular debts are everywhere, and plaster-like debtors are the most needed by major state-owned enterprises, and when everyone chats, they will take all kinds of debt prescriptions as talking points, but when they meet this kind of person, Yang Rui is really the first time.
"If you want to pass the audit in this way, it's impossible, and I'll report it to the Ministry of Health. Yang Rui glanced at Director Liu and said, "I think the ministry definitely doesn't want to see this kind of dramatic incident appear in a very serious drug review." ”
The first case of "not passing" in China, if it ends in such a anticlimactic way,
"We didn't want you to pass the review like this, we will explain and wait for a reply letter. "Director Liu is like a knife, and he doesn't seem to be afraid of Yang Rui's threat.
"The reply letter will be issued within the time limit, and if you want to explain, you will explain it when I go to the GMP committee. Yang Rui glanced at the man who followed the two, and guessed that this person was probably the one who used it to explain.
The latter and Yang Rui looked at each other for two seconds, smiled slightly, and said, "Actually, the explanation is just a matter of a few words." I heard that Commissioner Yang has an understanding of ethothiazide, and I happen to be a researcher of ethothiazide, so I know a little about DuPont's animal experiments. What I'm here to make today is that your claims about DuPont's animal experiments are wrong. ”
"Oh?" Yang Rui was not as interested as the other party thought.
Cao Baoming and Wang Guohua also came out at this time, although they didn't know what the situation was, they still stood on both sides of Yang Rui to strengthen their momentum.
"Let me introduce myself first, I am Yan Biao of the Pharmaceutical Institute. Specializing in Soviet drugs. "Comrade Yan Biao is quite proud, with his age, he can be famous and surnamed in a certain field, which is still very powerful.
Yang Rui was stunned for a moment and said, "There are still people who study this?"
Comrade Yan Biao, who was a little proud, was also stunned for a moment.
"Of course...... Soviet medicine was also very good. Yan Biao wanted to prove this, but he didn't know where to start.
Qin Hanchi coughed and said, "Old Yan." ”
"Oh, let's just say ethothiazide......"
"Let's talk about it as we go, I'm in a hurry to eat. Yang Rui couldn't beat a few people out, so he pushed the bicycle out.
Yan Biao hurriedly followed and said, "Okay, talk while walking." ”
"Give you two minutes, let's talk. Yang Rui said.
"Two minutes is not enough. ”
"It's been a minute and fifty seconds. Yang Rui used the method in the movie, and the effect was outstanding.
Yan Biao hadn't played this, and suddenly fell into Yang Rui's routine, thinking about it: "Regarding the animal experiments on ethylthiazide done by DuPont, I still happen to know some internal staff. I would like to give you a special explanation......"
"You've said that before, and it's useful to say something. ”
"Then I'll just say simply, the reason why ethothiazide caused the monkey to die has been identified, and it is a problem with the way of taking the medicine, not a problem with ethothiazide itself. ”
"Really?"
"Yes, DuPont has filed a reconsideration with the FDA on this issue, and it has been approved by the FDA. Now, clinical trials of ethothiazide are underway, indicating that errors in animal experiments do not affect the safety record of ethothiazide. ”
Yang Rui looked at Yan Biao and said, "The death of 12 monkeys and 6 monkeys didn't happen, did it?"
"This ......" Yan Biao shook his head and said, "Member Yang, I want to discuss serious academic issues with you, and I don't know how to answer you if you ridicule you like this." ”
"I'm not joking, as far as I know, the death of 6 out of 12 monkeys did happen, right?"
"This ...... Yes, but the FDA has endorsed DuPont's claim that the cause of death was an inappropriate way of taking the drug, not because of the safety of the drug. Yan Biao said seriously: "All drugs have a certain toxicity, and if you don't examine the method of taking the medicine, any good medicine may become a poison." ”
"The FDA did approve it, but if I remember correctly, the FDA was an agency in the United States. Yang Rui jumped out of the circle, and the sentence he suddenly asked couldn't be answered by Yan Biao.
Without waiting for others to answer, Yang Rui continued: "If the FDA's approval can replace the approval of the domestic drug regulatory agency, then China's customs can simply be handed over to the Americans to supervise, and we will save trouble, right?"
Qin Hanchi didn't dare to let Yan Biao take over this stubble, and said busily: "Let's talk about things, Commissioner Yang, since ethylthiazide failed in animal experiments due to improper medication, can your judgment of anti-heart rhythm drugs be changed?"
Yang Rui raised three fingers and said, "I'll say three points." First, the FDA has approved DuPont's statement, which does not mean that I have to approve it, we belong to different agencies, and if you want to save trouble, you can submit DuPont's reconsideration materials, and I will make a judgment. Second, if ethothiazide is not safe, it will affect my judgment of Libodine, because they are both anti-cardiac drugs, but if it is safe, it will not help Libodine's application for market entry. Third, Comrade Yan Biao, you said that you want to do a serious academic discussion, may I ask you, DuPont, have you resumed the long-term drug use experiment of animals?"
Yan Biao hesitated for a moment and said, "I don't know this very well......
"Then I don't think you're a Soviet drug expert. Yang Rui made a casual judgment, looked at the other party's face, and said: "DuPont may have persuaded the FDA to enter the clinical trial, but they have never used monkeys to do experiments again, in fact, if it is a simple misadministration, why not do the experiment again to prove innocence, right?"
"Experiments with monkeys are also expensive, and there is no need to ......"
"That's not enough. But DuPont itself is more convincing. Yang Rui said lightly, looked at his watch, and said, "Three minutes is enough, I can go." ”
"No...... No, I mean, Commissioner Yang, your statement is so biased that you can't guess what you haven't done and then draw conclusions. Yan Biao hurriedly trotted to keep up with Yang Rui.
Yang Rui lifted his hips and legs and got on the bicycle.
Qin Hanchi was anxious, grabbed the front of his car, and said, "Commissioner Yang, what Yan Biao said is that you can't let us die because of trumped-up charges." ”
Yang Rui turned his head to look at Qin Hanchi and said, "If you want to pin your hopes on a few monkeys for whether your application will be approved, let me put it this way, I can repeat the experiment of taking medicine for a long time." ”
He had done a full set of animal experiments in order to remove ferrite before, and it was not difficult to design a new set of long-term drug use experiments.
If it were other committee members, they might still be worried about the funds, but Yang Rui's funds have always been abundant.
Furthermore, doing a set of animal experiments does not mean that it is impossible to publish a paper.
As long as the paper can be published, Yang Rui has no problem doing this experiment in Huarui or the ion channel laboratory.
Qin Hanchi didn't dare to gamble like this, thought about it for a while, and quietly let go of the handlebar.