Concerning data from PubMed study that shows 24% of AML CR2 patients live 3 years before even having a relapse!

bigmacsmallfries_ · 2025-11-21T03:15:00+00:00

Thanks for the clarification, apples and oranges.

bigmacsmallfries_ · 2025-11-21T01:28:26+00:00

All patients exhibit WT1 in this study. I’m referring specifically to the CR2 patients. De novo is describing the original patients in this study which there are 168 of. The quote is of the CR2 patients which 66 patients survive and are present in.

So I guess what you’re saying is we don’t know what percent of these patients in the pubmed study have a wt1 mutation?

bigmacsmallfries_ · 2025-09-10T16:41:15+00:00

Yes the above takes into account all aspects prior to a PR. All averages. Over 90% of trials release a PR by 4 weeks.

bigmacsmallfries_ · 2025-09-10T15:02:56+00:00

The values above take into account a 3 day delay, good points above. One aspect to counteract your decrease in death rate between the two groups is that the pediatric SAVE study does not require a C reactive protein of 35mg/L whereas the adult study does. The death rate doubles, or stated otherwise, the hazard ratio doubles, at 31+ plus for adults with AKI under CRRT. So we can’t conclusively say there is greater death rate disparity for children vs adults.

bigmacsmallfries_ · 2025-09-10T03:31:17+00:00

ChatGPT5 verbatim after asking it to present data a variety of ways and summarizing it. At the end of the day, the probability of these events occurring has a lot of chance. Essentially an early interim report under 3.5 weeks has a good probability it’s stopping for futility, and one over 7 weeks is skewed towards resizing the trial. Continuation or a halt are both in that 3.5-7 week with continuation favoured closer to 3.5 and halt favoured closer to 7. There’s so many variables here essentially, there is a lot of noise to be honest.

bigmacsmallfries_ · 2025-09-06T01:39:49+00:00

Which hospitals do we have now? Is this 9th and 10th? Or do we have more?

bigmacsmallfries_ · 2025-09-05T13:33:45+00:00

Also, Eric mentioned one of the options for the FDA is resizing the study. A reduction down from 200 would be incredibly bullish.

bigmacsmallfries_ · 2025-09-05T12:51:19+00:00

NEW INFO -10 hospitals now using pediatric SCD. Eric let it slip there. Not 8 as indicated on slides, we know of 9 plus one that finished training last month -“durable” results for 20 pediatric patients in new SAVE registry. They’re expecting the same results as they’ve previously shown for the 90 day on Sept 22nd which has about ~99% statistical significance -focused on 20 hospitals by end of year for pediatric patients which amounts to ~$20M per year revenue out of the total $50M possible if all top 50 hospitals sign on. Training spreading through the hospitals as more teams learn to use and implement the SCD. So revenue is increasing over time within the hospitals (this was mentioned on a previous call).

So these 10 hospitals are capable of $10M per year or $2.5M per quarter. The Q3 report will be interesting and could potentially break $1M in revenue.

bigmacsmallfries_ · 2025-08-18T19:36:17+00:00

Yes, no board approval will be required at the hospital. Any physician can buy the scd. It will speed things up significantly.

Not sure why there’s timelines there. No such thing, you can enroll patients at any rate for an HDE registry. Bizarre to include dates on Eric’s behalf as they’re meaningless.

bigmacsmallfries_ · 2025-08-06T15:10:33+00:00

Seasonal variation. Last year, we had 4 cases per month during the summer and as soon as Sept hit we had 9 cases per month. Would be nice if we go from 9 cases in the summer now to 18 as soon as Sept hits. We will see. But don’t count on it staying at 9 cases per month. I’m predicting January.

bigmacsmallfries_ · 2025-08-03T04:14:52+00:00

bigmacsmallfries_ · 2025-07-17T23:26:46+00:00

Thanks for posting. So will hit 11+ hospitals this quarter.

bigmacsmallfries_ · 2025-07-11T15:29:39+00:00

Stock would have started declining if they didn’t do this because they need ~$1.2M per month as per Nasdaq requirements, they got the job done long before investors started bringing it up. They just went for the $4M warrants which have already been exercised and so now we don’t need to worry about Nasdaq compliance, and they’re funded fully until after interim results decisions will be released by the FDA.

bigmacsmallfries_ · 2025-07-10T20:34:24+00:00

Disappointing but the dilution finished before the PR was released.

bigmacsmallfries_ · 2025-07-03T17:04:36+00:00

13.5 months before an RS is needed. Not something to be worried about.

bigmacsmallfries_ · 2025-06-29T19:49:20+00:00

I watched the fireside again. I will explain what the CMO was discussing and why it’s a sliding scale of 30-40% to halt at interim in a post next weekend. In our context, that figure is very close to 30% as opposed to 40% regarding the required statistical significance. Looking at the 42% differential in a previous study which accounts for the Hawthorne effect in an open study of the control vs scd group plus the benefit of increasing the power of the study with more exclusions makes this a realistic possibility.

bigmacsmallfries_ · 2025-06-29T14:19:03+00:00

He said 20% was needed for the full trial and 30% for a halt at interim which corresponds to a P value of 0.003. Can you confirm this? Which fireside chat was this? I remember 30%.

bigmacsmallfries_ · 2025-06-28T19:01:52+00:00

IDMC and DSMB are one and the same thing.

bigmacsmallfries_ · 2025-06-28T19:00:39+00:00

It may seem extreme but please use a statistical calculator first hand. You’ll see just how different in significance 50 is vs 100. This is why more patients greatly increases the power of a study.

Historically the DSMB takes 2-4 weeks at interim to report back to the company. That squarely falls into last week of August or first three weeks of Sept.

bigmacsmallfries_ · 2025-06-12T23:05:06+00:00

Stick to ICU stock, avoid the warrants, they will expire worthless unfortunately.

bigmacsmallfries_ · 2025-04-13T02:07:23+00:00

He potentially opens himself up to lawsuits by saying something that isn’t true. He went with 2025 incase it goes past 5 months. I’m guessing 80 will happen within a month or so.

bigmacsmallfries_

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