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Posted On: 06/02/2025 9:12:45 AM
Post# of 153831
hoops
I thought I would ask ChatGpt your question, so here is her reply. I know that we have one member of our group who does not like her, but here you go,
Your question gets right to the heart of the current tension around CytoDyn’s strategy, and it’s a smart observation. Let’s unpack the most likely reasons for the company attending ESMO Breast Cancer in Berlin but not ASCO in Chicago, despite the perception that ASCO carries more global prestige.
1. Strategic Targeting: ESMO Breast Cancer was More Focused
ESMO Breast Cancer 2024 was specifically focused on breast cancer, including mTNBC, whereas ASCO has a broader oncology scope and is more competitive for attention.
The poster presentation at ESMO gave CytoDyn a relatively high-visibility platform in a focused, relevant audience—mostly breast cancer specialists and European oncologists—without being drowned out by hundreds of presentations.
TNBC emphasis was significant at ESMO: multiple sessions addressed immunotherapy, PD-L1, ADCs, and metastatic TNBC. That’s ideal terrain for presenting the survival data CytoDyn just published.
2. Europe as a Regulatory Foothold
The fact that they “loaded the plane” implies a substantial team effort, likely including meetings with European regulatory consultants or potential partners.
EMA (European Medicines Agency) may be viewed as less politically entangled than the current FDA. If management believes the FDA is still unreceptive (or tainted by past disputes), pursuing EMA first could offer:
A faster path to approval via compassionate use or orphan designation.
Leverage for FDA reconsideration once European validation exists.
Leronlimab’s clean safety profile and immunomodulatory mechanism could appeal more to European regulators, who often favor immune restoration and quality-of-life metrics.
3. Management Skepticism Toward the FDA
Your speculation that CytoDyn may lack confidence in the FDA is reasonable. The company’s history with the FDA—rejected BLA filings, disputes over trial design, and the ongoing fallout from prior leadership—suggests lingering mistrust.
Attending ASCO would have raised visibility with the U.S. oncology establishment, which may include critics or skeptics still influenced by the old narrative around CytoDyn.
By contrast, ESMO was a cleaner slate—an opportunity to reset impressions with an international audience.
4. Logistics, Cost, and Focus
ASCO is expensive. CytoDyn is financially constrained. Unless you have a late-breaking abstract or a major Phase 3 study, it’s hard to stand out at ASCO.
ESMO was a better fit for the early-but-promising survival data and allowed for one-on-one meetings with key opinion leaders and pharma representatives in a more intimate setting.
Bottom Line
It’s likely a mix of:
Targeting a more relevant and receptive audience (ESMO Breast Cancer).
Sending signals of a pivot to European regulatory pathways (EMA).
Avoiding political or institutional baggage with the FDA and ASCO.
Resource constraints and return-on-investment calculations.
They may be laying the groundwork for an EMA submission, partnership, or follow-on trials in Europe, which might eventually back-pressure the FDA into action. If EMA gives leronlimab a serious look, that becomes a powerful narrative turnaround.
I thought I would ask ChatGpt your question, so here is her reply. I know that we have one member of our group who does not like her, but here you go,
Your question gets right to the heart of the current tension around CytoDyn’s strategy, and it’s a smart observation. Let’s unpack the most likely reasons for the company attending ESMO Breast Cancer in Berlin but not ASCO in Chicago, despite the perception that ASCO carries more global prestige.
1. Strategic Targeting: ESMO Breast Cancer was More Focused
ESMO Breast Cancer 2024 was specifically focused on breast cancer, including mTNBC, whereas ASCO has a broader oncology scope and is more competitive for attention.
The poster presentation at ESMO gave CytoDyn a relatively high-visibility platform in a focused, relevant audience—mostly breast cancer specialists and European oncologists—without being drowned out by hundreds of presentations.
TNBC emphasis was significant at ESMO: multiple sessions addressed immunotherapy, PD-L1, ADCs, and metastatic TNBC. That’s ideal terrain for presenting the survival data CytoDyn just published.
2. Europe as a Regulatory Foothold
The fact that they “loaded the plane” implies a substantial team effort, likely including meetings with European regulatory consultants or potential partners.
EMA (European Medicines Agency) may be viewed as less politically entangled than the current FDA. If management believes the FDA is still unreceptive (or tainted by past disputes), pursuing EMA first could offer:
A faster path to approval via compassionate use or orphan designation.
Leverage for FDA reconsideration once European validation exists.
Leronlimab’s clean safety profile and immunomodulatory mechanism could appeal more to European regulators, who often favor immune restoration and quality-of-life metrics.
3. Management Skepticism Toward the FDA
Your speculation that CytoDyn may lack confidence in the FDA is reasonable. The company’s history with the FDA—rejected BLA filings, disputes over trial design, and the ongoing fallout from prior leadership—suggests lingering mistrust.
Attending ASCO would have raised visibility with the U.S. oncology establishment, which may include critics or skeptics still influenced by the old narrative around CytoDyn.
By contrast, ESMO was a cleaner slate—an opportunity to reset impressions with an international audience.
4. Logistics, Cost, and Focus
ASCO is expensive. CytoDyn is financially constrained. Unless you have a late-breaking abstract or a major Phase 3 study, it’s hard to stand out at ASCO.
ESMO was a better fit for the early-but-promising survival data and allowed for one-on-one meetings with key opinion leaders and pharma representatives in a more intimate setting.
Bottom Line
It’s likely a mix of:
Targeting a more relevant and receptive audience (ESMO Breast Cancer).
Sending signals of a pivot to European regulatory pathways (EMA).
Avoiding political or institutional baggage with the FDA and ASCO.
Resource constraints and return-on-investment calculations.
They may be laying the groundwork for an EMA submission, partnership, or follow-on trials in Europe, which might eventually back-pressure the FDA into action. If EMA gives leronlimab a serious look, that becomes a powerful narrative turnaround.
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