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: Hidemaru Yamaguchi - Citi - Analyst
: Hello. Can you hear me okay?
Question: Hidemaru Yamaguchi - Citi - Analyst
: So I have three questions. I'll try to be very brief. Thank you for the explanation. It was very helpful. The first question is that after this TL-01 OS data,
the financial markets seem to be a bit worried about the probability of success or approval of probability at the PDUFA date in December. And
direct I'd like to make a basic question once again but is it a dual endpoint data and the PFS is already status significant, OS was a bit weakish, but
it's still trending -- the number is trending.
So with these conditions after this OS data updated, is it fair to say that the probability of -- the probability is go down or not really. My understanding
is that PFS is good enough to get approval. But is there something new things happening to make you guys less confident about our probability
of the data? That's the first question.
Question: Hidemaru Yamaguchi - Citi - Analyst
: Right. So still that during the point, meaning one of which is not significant, meaning the trial itself is a success, right?
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SEPTEMBER 17, 2024 / 12:00PM, 4568.T - Daiichi Sankyo Co Ltd WCLC/ESMO Briefing
Question: Hidemaru Yamaguchi - Citi - Analyst
: Okay. And second quick question is that this non-squamous things, including QCS. It looks like you have some idea of why there's a difference
between non-squamous and squamous, especially the top two membrane or penetration into the cells. Do you have any idea why there is a sort
of difference between the non-squamous and squamous, and also how FDA is viewed this sort of difference? And is there any scientific evidence
to see the difference of non-squamous and squamous at this point?
Question: Hidemaru Yamaguchi - Citi - Analyst
: The final question is that regarding the new generation of 9606. It is -- it looks pretty [pre-mid] at this point because you are still in the process of
raising doses. I understand that and it looks very safe in all things. But also, there are some commentary and you pointed out as well. There's a new
sort of potential side effect especially on skin tox has been emerging, so already only one or two.
Do you think this is going to be dose remitting factor in the future? Or it really doesn't matter? And how do you -- how long do you see the more
response, especially like cancer, ovarian cancer, which should be the main target of this indication, the drug?
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