RE: Curative potential14 Oct 2025 19:30
Pingu once again misleading and showing a complete lack of integrity.
âMD Anderson approached us first.â
⢠There is no evidence to support this claim. MD Anderson is a trial site and approved the study, but nothing suggests they initiated contact. Presenting opinion as fact is misleading.
âRidiculously early paediatric protocol amendment request by MDA.â
⢠This is misleading. Early paediatric protocol amendments are common in serious diseases with high unmet needs, especially in oncology, and do not indicate anything exceptional.
âRidiculously early paediatric approval by FDA, implying compelling data.â
⢠There is no evidence of compelling data. Early paediatric FDA approval is typically based on safety data from adult cohorts and is used to accelerate trials in life-threatening conditions. It is not granted due to proven efficacy.
âFunded into the New Year.â
⢠This is speculation. There is no confirmed funding position. Paediatric expansion increases trial costs, and there is still no clarity on spending related to CBR, Estonia (if it progresses at all), or general operating costs.
âInvited to present at the invitation-only DCNK Summit.â
⢠This is being exaggerated. Speaking at a conference does not validate clinical progress or financial strength. It is simply a networking opportunity and nothing more.
âEstonia expansion creating an accelerated gateway to Europe and the rest of the world.â
⢠This is false. It is only a Letter of Intent, not a binding agreement. There is no confirmed Estonian government support, no operational facility, and strict conditions must be met. Referring to this as âexpansionâ or a âgatewayâ is misleading.
âPassed safety first cohort (arguably the biggest challenge).â
⢠Passing the first safety cohort is expected in a Phase 1 trial, particularly at low doses. The main risk lies ahead with higher dosing and especially paediatric dosing, where any adverse event could halt the entire trial. This is far from the âbiggest challenge.â
âMDA IRB approval to commence paediatric expansion (they own patient data).â
⢠This is a routine procedural step and not a significant milestone. Claiming ownership of patient data as a major point is irrelevant and adds nothing meaningful.
âP1 cleared 6 months alive, P2 3 months, P3 rapid MRD. Efficacy indications good on half recommended dose.â
⢠These are anecdotal observations, not evidence of efficacy. Phase 1 trials are designed for safety and dosing only. Presenting survival timelines or MRD changes as proof of efficacy is misleading.
âIndependent Review Board reviewing data now. External verification coming.â
⢠IRB data review is a standard requirement in clinical trials and does not indicate any special progress. An IRB review is not âexternal verification.â Unless there is confirmation of an independent third-party audit, CRO validation, peer-reviewed publicati