GREY:IMVIF - Post by User
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qwerty22on Dec 03, 2020 1:11pm
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RE:RE:RE:RE:RE: Webcast
RE:RE:RE:RE:RE: Webcast I finally got to listen to the Q&A part. It got a lot better. I like Dorigo's answer on maintainance therapy. I like the fact it drew out an answer from Fred about the next step. It seems they continue with these late treatment patients to get first approval, that makes sense to me from a regulatory perspective even if ultimately the drug is better as maintainance after 1st line.
I liked the whole Q&A. I like the analysts ask probing questions, it gets the responses we need. I like the passion the KOLs have for this drug and their ability to translate some of the dry numbers like ORR and PFS into real patient experiences. I just don't understand why the company is so adverse about talking about the future until they are pressed to do it. Both Joanne's and Mark's bits are just empty of content, thankfully we have the KOLs to counteract that. Fred was good.
Anyway I think it's all good. I didn't feel there was much negativity from the analysts just a desire to understand more deeply. If you take the KOLs and Fred together then I guess there is a path forward here. Let's hope this results in some positive notes from the analysts.
Breakthorough wrote: What I got from the answers to JB (WF) and JP (HCW) is mainly: - They want to analyze the translational data before making a decision for Registrational Trial. It should be done in 2021 (in nov 12 they said Type B meeting with FDA after actual trial is complete in Q1). - Asked ab the possibility of more PR coming from actual SD, Ors acknowledged that it was possible. BUT that the important thing was the duration of benefit. It compared it with first FDA approval of Pembro (Melanoma). - Ors also suggested that the path of DPX could be the same of Pembro in relation to future passing to prior lines of therapy.