Jan. 26 at 11:39 PM
$VXRT
Straight to the Point
Here’s some more info from the clinical trial auditor, a former Big Pharma professional who specializes in forensic reconstruction of efficacy datasets, the writing of high-level clinical study reports, and M&A strategic due diligence.
This is short. It cuts to the chase and separates the signal from the noise.
Enjoy...
“Here is the simple logic explaining why reducing the study size from 10,000 to 5,000 people is actually a massive "Buy Signal" for Vaxart.
1. The Starting Assumptions (Baseline) Placebo Rate: We assume that in the real world (with the KP.2 strain), about 10% of people get infected if they have no protection. mRNA Performance: We assume that the old mRNA vaccines are no longer very effective against KP.2. They only reduce the infection rate slightly, from 10% down to 9%. (This means the mRNA arm still shows a very high number of sick people).
2. The VAAST Performance (The Game Changer) VAAST Pille Rate: We assume that the Vaxart pill works exceptionally well. Instead of 10%, only 1% of people in this group get sick.
3. The "Pooled" Math (The Sentinel Signal) In the early stages of the study (the Sentinel phase), the researchers look at the average of both groups combined (blinded data): Calculation: (9% sick in mRNA arm + 1% sick in VAAST arm) divided by 2 = 5% Average Infection Rate.
The Result: When the researchers saw that the combined infection rate was only 5% (even though the virus was spreading at 10% outside), they realized the study was working much faster than expected.
4. Why reduce the number of participants?
Statistical Power. In math, if the difference between two things is small (like 9% vs. 10%), you need a huge crowd (10,000 people) to prove it’s not just luck.
The Vaxart Gap: But if the difference is HUGE (like 9% vs. 1%), the math becomes "High Significance" (
$P = 0.001$) much faster. You only need half the people (5,000) to conclude that the result is 99.9% certain.
Conclusion: The reduction of the study size is proof that the difference between the Vaxart Pill and the mRNA vaccine is massive. The researchers don't need 10,000 people anymore because the success of the pill is already mathematically obvious from the first few hundred participants.
Verdict: The 5k reduction isn't about saving money; it’s about the fact that VAAST is crushing the competition."
