What is your perspective of the adaptive design they spoke of to address any difference that may arise with the control arm for phase 3 vs the historical data that they have been using which speaks of survival at 3-5 months? Having the opportunity to use an adaptive design sounds appealing but i'm wondering if there are any drawbacks to it.
Also, are current salvage treatment doing better than they were some half a decade or more ago? It appears the most commonly used salvage treatments are CCNU, temozolomide re-challenge and carboplatin.
Any new concerns about the control arm outperforming val-083 or does the MOA differentiation give you confidence at this stage? I'm cautiously optimistic!
I'm excited about the phase 2 trials in that they will be using the MGMT biomarkers to identify patient types a) where temozolomide becomes resistant or doesn't work and b) where val-083 appears to work well. That would bump dmpi from salvage to first line very quickly.
Thanks.
Recent KTRA News
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 09/20/2024 08:20:01 PM
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