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: Nina Brito Garg - Deutsche Bank - Analyst
: Hello, thank you for taking my question, I just wanted to ask a little bit more about the factors that are going into your decision to potentially
withdraw drug from market and how you're thinking about what you need to hear from the discussions that you're having over the next eight
weeks from regulators and (inaudible) of community in order to make that determination?
And then also, if you can give us some clarity on potentially when we could see that sort of determination made. I know it's still early and hard to
determine that, but anything that you could share would be helpful. Thank you.
Question: Nina Brito Garg - Deutsche Bank - Analyst
: And then if I can just ask one more follow-up. Just in terms of the decision that you've made to kind of pause promotion on the product right now.
I guess is there anything that you can share kind of on, you know, the benefit risk that you saw in the study? I know that you did say that the safety
and tolerability looks acceptable. But, just curious what went into that decision? Or is there something specific, I guess, in the data set that you saw
that kind of led to that decision?
Question: Karin Johnson - Goldman Sachs - Analyst
: Yes, good morning, guys, maybe one from us, what could you share what the change in slope and ALS FSR was observed in the drug? And then in
the placebo arm and did you see any change in one versus the other versus kind of like what you'd expected that drove this result? Did the drug
do worse than it had previously or the placebo do better and things like that? Thanks.
Question: Umer Raffat - Evercore ISI - Analyst
: Hi, guys. Thanks for taking my question. A couple here, if I may. First, I'm just trying to reconcile your press release versus the release from the Italian
Group, which (technical difficulty) there is a clinical step forward for medicine. How could it be that maybe there is a signal in that study and
absolutely no signal in this one or maybe there is no signal in the other study. I'm curious how you think about the totality of the picture?
Secondly, are you a 1,000% sure, there's absolutely no subgroup, which had any trend of activity which could warrant some sort of follow-on work,
be that definite ALS like your prior trial or less than 12 months from diagnosis or [SVR book] 70 bulbar onset, any of those? And then finally, Jim,
how long is this cash runway? If you actually do withdraw the drug from the market?
Question: Charlie Yang - Bank of America - Analyst
: Hey, thanks, guys. I just wanted to, maybe just get a little more details regarding how the 2025 or 2026 count expectation there, like what are we
actually expect results wise, given what we have seen today. And could that have any potential change in terms of how kind of you'll be thinking
about the direction of (inaudible) and that maybe, if you can just clarify the interim analysis that you referred to earlier until when can we expect
to see those analysis? Thank you.
Question: Charlie Yang - Bank of America - Analyst
: And maybe I'll have one more follow-up just regarding the PHOENIX trial. So, are we going to see the overall survival data for PHOENIX channel?
Or what's the plan and maybe I missed it earlier. Thank you.
Question: Graig Suvannavejh - Mizuho - Analyst
: Good morning. Starting to see the data. I was just curious, as we look on the forward, I think it's important for investors to get a view of whether
the company does still have a viable future going forward. And so with that in mind, obviously with the pipeline that you have now, given the cash
that you have now, is there any current view around perhaps even looking beyond what you have now to perhaps look to add other things that
further diversify the company or with what you have right now, perhaps you feel that's the best that you want to kind of present to investors as
the opportunity going forward. Thanks.
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