I wish I knew how to accurately complete a Kaplan-
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Posted On: 05/01/2025 1:36:11 PM
I wish I knew how to accurately complete a Kaplan-Meier model to conduct a true "worst-case" survival analysis, especially given that median overall survival (mOS) couldn’t be calculated at the 12-month mark. If anyone has experience with Kaplan-Meier modeling and can walk through how to input this into a tool like StatsKingdom’s calculator, please share.
Here’s how I’m interpreting the available data:
- 13 patients reached 6 months (perhaps less)
- at least 15 were still alive after 12 months (based on previously released information)
- 5 are alive at 48 months, and possibly more now.
Using these as reference points, I estimate an average survival of ~16 months, which makes an 18-month average seem entirely reasonable—especially when factoring in that the first group of 13 likely included some of the sickest patients, who may not have even averaged 6 months. But I cheated and used ChatGPT and it calculates 20 months mOS:
While I absolutely don’t agree with how the FDA has handled this in terms of transparency or support, I also recognize that the bulk of the responsibility lies with CYDY management. Yes, we're a tiny player and can’t operate like Big Pharma, using influence or inflated studies to reach approval thresholds. That just means we had to execute flawlessly, with discipline, integrity, and laser focus—none of which consistently happened.
When I first invested, I felt the HIV indication had already largely de-risked the investment. Cancer was my core focus, and everything else was icing on the cake. In hindsight, chasing multiple indications simultaneously may have been well-intentioned, but ultimately diluted attention and resources. Combine that with Amarex’s failures—poor data handling, botched submissions—and we ended up here.
That said, I still believe the science behind leronlimab is real and powerful. The company now appears to be back on track, with a more focused approach, and if it continues to operate with transparency and scientific rigor, credibility can be rebuilt—with the FDA, investors, and potential partners. Given the molecule’s promise, I truly believe it's not a matter of if, but when.
Here’s how I’m interpreting the available data:
- 13 patients reached 6 months (perhaps less)
- at least 15 were still alive after 12 months (based on previously released information)
- 5 are alive at 48 months, and possibly more now.
Using these as reference points, I estimate an average survival of ~16 months, which makes an 18-month average seem entirely reasonable—especially when factoring in that the first group of 13 likely included some of the sickest patients, who may not have even averaged 6 months. But I cheated and used ChatGPT and it calculates 20 months mOS:
While I absolutely don’t agree with how the FDA has handled this in terms of transparency or support, I also recognize that the bulk of the responsibility lies with CYDY management. Yes, we're a tiny player and can’t operate like Big Pharma, using influence or inflated studies to reach approval thresholds. That just means we had to execute flawlessly, with discipline, integrity, and laser focus—none of which consistently happened.
When I first invested, I felt the HIV indication had already largely de-risked the investment. Cancer was my core focus, and everything else was icing on the cake. In hindsight, chasing multiple indications simultaneously may have been well-intentioned, but ultimately diluted attention and resources. Combine that with Amarex’s failures—poor data handling, botched submissions—and we ended up here.
That said, I still believe the science behind leronlimab is real and powerful. The company now appears to be back on track, with a more focused approach, and if it continues to operate with transparency and scientific rigor, credibility can be rebuilt—with the FDA, investors, and potential partners. Given the molecule’s promise, I truly believe it's not a matter of if, but when.
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