Online Class Notes (Ally)

Vocabulary

move：搬家

ordeal: 磨难

dodged a bullet: 躲过一劫

work leave

i just work online
I just work online/remotely

you have to be admitted from many people
your leave has to be approved by many people

last year may holiday
last labor day holiday/the labor day holiday/may first holiday last year

it is not effective than what I thought before
it is not as effective as what I thought before （一样）
it is less effective than what I thought before. (不一样)

they usually don’t answer them directly
they usually don’t give a direct reply/direct answer

she can help me to express myself well
she can help me to interpret

may doubt the results
may doubt the efficacy of the trial/drug

maybe next meeting we will told our partner our final decision
maybe next meeting we will tell our partner about / our final decision

maybe the FDA will challenge you that the patients that you’re enrolled is the same in and outside China
maybe the FDA will challenge/raise a concern that the patients enrolled are the same in and outside China

the point that we want to argue with them is the CDE
our strongest argument is the reply from the CDE

we have received the reply from CDE and our final decision is to make the protocol division. If we do not make the amendment, maybe we will enroll the patients who will be different than abroad… have effect on the efficacy data interpretation.

we have received the reply from CDE and they gave us a very strong answer. The CDE said all the patients who are enrolled must have already gotten adequate therapies, which means adequate cycles of R and A. They understand that the frail patients who do not have good cardiac functions may not have received the regimens for the first round treatment. But for all other patients who can, they must receive full cycles of … Based on that, our final decision is to make the protocol revision. If we do not make the amendment, maybe we will enroll mixed populations, and it would have a negative effect on the efficacy data interpretation.