the share price and partnership do not require approvals. that is what i stated, yesterday and many times prior. that is what i want you to be aware of. approval processes exist, right? and they take time right? that's all. its not bad. its not negative. its just the most basic condition of the industry.
i haven't stated 5 to 10 years away in quite some time, because it isn't true any more. there are possibilities for "quick approval". oncology unmet needs are very commonly approved via accelerated approval. mss-crc and tnbc are possible because of the unmet refractory population need, the immunological moa, and the established use of ORR as an oncology surrogate endpoint. BUT, just beuing real, jjust stating the very basic regulatory matters, any approval, including accelerated, still requires 1) a complete BLA or NDA, 2) proof manufacturing readiness 3) a confirmatory phase 3 trial that is "underway" which is defined as having activated clinical sites and enrollment initiated. THAT ISNT A BAD THING. its just the very basics of the regulatory process that every pharma company faces.
*** BUT AGAIN AS I OFTEN STATE... ***
CYTODYN CAN GO TO $1 $2 $5 WHATEVER...
WITHOUT ANY APPROVAL.
CYTODYN CAN BE PARTNERED WITH BP...
WITHOUT ANY APPROVAL.
that's a pretty positive outlook, no?
approval is not at all what matters. data matters. data is imminent. i believe there will be positive activity shown including PRs. i have no idea what to expect for ORR. it could be pretty low. it could be quite high. cancer is complex, MSS is a tough one, evasion will occur relatively quickly. but, leronlimab has multiple MOA specifically aligned with fighting cancer, and metastasis, and mss, and liver mets. liver mets is everything is MSS. anything is possible imo between i'll say 10% ORR and 40% ORR. and i believe anything 20% and above is an excellent result.
that's a pretty positive outlook, no?
also i have shared my research that shows that there is only 1 other drug hitting high ORR in the MSS pipeline, which also addresses the full spectrum of mss-crc patients, including kras mutation and liver mets. leronlimab will have activity for that same full spectrum. the other drug has not yet begun its p2, and it will be about 18 months behind cytodyn once that starts. and its kinda stuck in a dose finding exercise which could delay a bit further. CURRENTLY JUST ONE DIRECT COMPETITOR HERE.
that's a pretty positive outlook, no?
i haven't stated 5 to 10 years away in quite some time, because it isn't true any more. there are possibilities for "quick approval". oncology unmet needs are very commonly approved via accelerated approval. mss-crc and tnbc are possible because of the unmet refractory population need, the immunological moa, and the established use of ORR as an oncology surrogate endpoint. BUT, just beuing real, jjust stating the very basic regulatory matters, any approval, including accelerated, still requires 1) a complete BLA or NDA, 2) proof manufacturing readiness 3) a confirmatory phase 3 trial that is "underway" which is defined as having activated clinical sites and enrollment initiated. THAT ISNT A BAD THING. its just the very basics of the regulatory process that every pharma company faces.
*** BUT AGAIN AS I OFTEN STATE... ***
CYTODYN CAN GO TO $1 $2 $5 WHATEVER...
WITHOUT ANY APPROVAL.
CYTODYN CAN BE PARTNERED WITH BP...
WITHOUT ANY APPROVAL.
that's a pretty positive outlook, no?
approval is not at all what matters. data matters. data is imminent. i believe there will be positive activity shown including PRs. i have no idea what to expect for ORR. it could be pretty low. it could be quite high. cancer is complex, MSS is a tough one, evasion will occur relatively quickly. but, leronlimab has multiple MOA specifically aligned with fighting cancer, and metastasis, and mss, and liver mets. liver mets is everything is MSS. anything is possible imo between i'll say 10% ORR and 40% ORR. and i believe anything 20% and above is an excellent result.
that's a pretty positive outlook, no?
also i have shared my research that shows that there is only 1 other drug hitting high ORR in the MSS pipeline, which also addresses the full spectrum of mss-crc patients, including kras mutation and liver mets. leronlimab will have activity for that same full spectrum. the other drug has not yet begun its p2, and it will be about 18 months behind cytodyn once that starts. and its kinda stuck in a dose finding exercise which could delay a bit further. CURRENTLY JUST ONE DIRECT COMPETITOR HERE.
that's a pretty positive outlook, no?
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