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Biotech / Medical : Immunomedics (IMMU) - moderated
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From: sysiphus11/25/2024 10:08:26 AM
2 Recommendations

Recommended By
jhcimmu
rodneyh07

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Matt Nachtrab on SAVA

While the tone on the call was not good, simufilam is absolutely not dead and the company is not winding down operations. The $sava simufilam result is very similar to other large phase 2 studies done on AD and if you look $sava outperformed most of these. Now we look at the data and see why simufilam is outperforming 80% of expected placebos even with an historically great performing placebo in RETHINK.

Here are what the next steps are for $sava:

1. Close and lock Refocus and combine results with Rethink - Perform full review of data. The P-value of .4 shows that simufilam performed better than 80% of placebo outcomes. We need to review all of the subgroups of the data to see what really happened in the study. If we can pull the cover back, we may see (just like $lly and $biib) that we can focus the data on a portion of the populations that causes the drug arms to slightly outperform over and over again.

2. What we have now is a Large placebo controlled phase 3 dataset, but we also have the ability to modify the SAP and go forward with the data from these trials to the FDA.

3. We need to understand why the placebo performed at a historically great level. It could be because the plasma pTau181 did not get stratified like the donanemab study. As I was saying MMSE is no longer a good way to do cohort analysis of AD. It should be done based on a screening biomarker. The placebo came in at 3.2 pt decline on ADAS-cog12! The 4reatment was over 12.5% better than that. Think about what had to happen for it to be 3.2... Mild would have to be lower than moderate.

When I break down the 12 month score for lecanemab, low/medium tau did 2.92, High tau did 7.67 and a total of 4.45. The spread in adas-cog13 was 4.75 points!

So if you look at $sava you can see some scenarios of what mild and moderate could have come in at to line up with lecanemab. What IF we analyze the data the some way... do we get similar significant results?

4. We need to analyze the large % of 18 month finishers that we have now and see if the additional time caused any separation.

$sava needed to stop the trial for a few reasons:
1. The clinical trial sites may start just dropping patients off
2. Cash should be conserved to perform the steps above
3. Because RETHINK did not meet stat sig there is a chance that the FDA would tell $sava to pause

I expect 2-3 months to pour through this data and I expect we find some likely effectiveness in the simufilam treatment that will breath life to the drug again.

I am not selling down here. I wait for the data. That said, the upside is no longer the $500+ a share dreams... it is much lower.
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