Machiavelli I agree. We meet the primary endpoint set in conjunction with the FDA in a double blind, placebo controlled study for moderate to severe patients, outscoring current standard of care and market cap is approx 50 million dollars. Little changed today except share price and believe it or not some actually care about the science of the MOA and its applications for better treatments for AD regardless of share price. What we've heard recently is that the company wouldn't be able to increase the SIB (which is in fact reversing and not delaying ALZ) and then when we do, the goalpost get moved. The company in conjunction with the FDA set the phase 2b exploratory trial P-value at .01. Obviously to pass a phase 3 it will be lower. These patients weren't data mined. They weren't scanned. They simply had to meet the 4-15 mmse score requirement according to CEO and still hit .07, just outside tolerance. The fact is, the drug almost hit a phase 3 endpoint that would have been better than the current SOC at week 12 by .02. This drug will be advanced to further study.
Let's face it. Every MOA trialed (and there aren't many who do try this population) hopes to hit that magic note where the results are so definitive that the FDA has to approve quickly. We did not hit that sweet spot in 12 weeks. That's what the market is disappointed with since research is so thorough here. what we did see is confirmation that all that animal research IS transferable to humans and regeneration IS taking place 12 weeks in. I can't wait to see the 17 week data that I pointed out was so important months ago. We'll see that in the near term according to Alkon and he said he couldn't quantify specifics but that he could share that it looks very encouraging, especially when compared to placebo. Keep in mind SOC falls off sharply after week 12.
A better delta at week 17 would be major validation of the MOA. JMHO
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