The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Yo Mizuno - Tokio Marine Asset Management Co., Ltd., Research Division - Analyst
: I'm Mizuno from Tokio Marine Asset Management. I'm sorry to be so inquisitive about 8201. If an accelerated application has become available, I
believe it means that you have result to -- resolved the issue of manufacturing capacity. In your discussion with AstraZeneca about what you are
going to do next, have you reached the conclusion that the manufacturing capacity will not be your bottleneck? I'm sure you have discussed about
the expansion of the facilities, since you are getting a lot of money. Do you ever consider things like accelerating the expansion?
Question: Yo Mizuno - Tokio Marine Asset Management Co., Ltd., Research Division - Analyst
: Just want to confirm that if the first application for the approval in the United States is approved, all the CMC-related matters will be applicable to
the future indications? What FDA does recently is that they skip that part. And for an expanded indications, as long as the clinical data are good, it
is very likely that the FDA review will be much faster, or is it correct to say that the -- that's what it is to be expected?
Question: Yo Mizuno - Tokio Marine Asset Management Co., Ltd., Research Division - Analyst
: Also, there was a part in your presentation that I couldn't follow about gastric cancer in the U.S. and Europe. Is the purpose of those studies to be
able to file for application? Or is that because you need to conduct Phase II and Phase III anyways?
Question: Yo Mizuno - Tokio Marine Asset Management Co., Ltd., Research Division - Analyst
: I'm sorry, but I have one more question. Edoxaban in Europe is doing really well. But if oncology is growing so much internally in your company,
it could be possibly a kind of fragmented business. Is it correct to assume that this will not be your non-core business? Or is it still possible to be
non-core business in a certain case?
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