"I wonder if I could caution you on the hope for "accelerated approval.""
You could... You should... And thanks for the commentary, Ken.
"A company still needs to compile an NDA even for accelerated (conditional) approval. And this is a huge project... generally takes a year, and requires manpower that CYDY might not have..."
I tend to focus on the science, but was pleased to see that dostarlimab, based on excellent data, had a shortened regulatory path/timeline towards conditional approval. And getting it into patients. Roughly a year's time from published trial results to conditional approval for dMMR endometrial cancer. And six months after that, the drug was approved for "all dMMR solid tumors." But yes, I'm sure that took a great deal of hard work getting the NDA together. And certainly right now, Cytodyn doesn't have the manpower to make that kind of effort. My hope--my expectation--would be that a partner would shoulder the load. And as that process became public I would also hope the share price would reflect that. (!)
Here's some additional details courtesy Google AI:
"Dostarlimab received its first FDA accelerated approval in April 2021 for endometrial cancer, roughly 3–4 years after initiating clinical trials like GARNET.
Key Details on Dostarlimab (Jemperli) Approval Timeline:
Initial Approval: In April 2021, the FDA granted accelerated approval for dMMR recurrent/advanced endometrial cancer.
Trial to Approval Time: The GARNET trial data, which supported this, was presented in 2020, with approval following in early 2021.
Full Approval: The drug moved from accelerated to full FDA approval for dMMR endometrial cancer in February 2023.
BTD Designation: While early, rapid approvals were granted based on trial data, a formal Breakthrough Therapy Designation was later granted for, for example, dMMR/MSI-H rectal cancer in December 2024, based on exceptional trial results.
Dostarlimab also received separate accelerated approval for all dMMR solid tumors in August 2021."
That last line could have great implications for leronlimab in low or nil PD-1/PDL-1 expression... But of course, it all depends on great data. So we wait.
You could... You should... And thanks for the commentary, Ken.
"A company still needs to compile an NDA even for accelerated (conditional) approval. And this is a huge project... generally takes a year, and requires manpower that CYDY might not have..."
I tend to focus on the science, but was pleased to see that dostarlimab, based on excellent data, had a shortened regulatory path/timeline towards conditional approval. And getting it into patients. Roughly a year's time from published trial results to conditional approval for dMMR endometrial cancer. And six months after that, the drug was approved for "all dMMR solid tumors." But yes, I'm sure that took a great deal of hard work getting the NDA together. And certainly right now, Cytodyn doesn't have the manpower to make that kind of effort. My hope--my expectation--would be that a partner would shoulder the load. And as that process became public I would also hope the share price would reflect that. (!)
Here's some additional details courtesy Google AI:
"Dostarlimab received its first FDA accelerated approval in April 2021 for endometrial cancer, roughly 3–4 years after initiating clinical trials like GARNET.
Key Details on Dostarlimab (Jemperli) Approval Timeline:
Initial Approval: In April 2021, the FDA granted accelerated approval for dMMR recurrent/advanced endometrial cancer.
Trial to Approval Time: The GARNET trial data, which supported this, was presented in 2020, with approval following in early 2021.
Full Approval: The drug moved from accelerated to full FDA approval for dMMR endometrial cancer in February 2023.
BTD Designation: While early, rapid approvals were granted based on trial data, a formal Breakthrough Therapy Designation was later granted for, for example, dMMR/MSI-H rectal cancer in December 2024, based on exceptional trial results.
Dostarlimab also received separate accelerated approval for all dMMR solid tumors in August 2021."
That last line could have great implications for leronlimab in low or nil PD-1/PDL-1 expression... But of course, it all depends on great data. So we wait.
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