Investorvillage. Willy Coyote dixit:
Humanity has now an RSV vaccine that WORKS
The RSV vaccine works well.
It's perfectly justifiable to ignore the data from the moms who got vaccinated past 33 weeks of pregnancy. Some of you said doing so would be fake analysis. No, it's perfectly justifiable. In fact, including the >33 weeks moms would be the fake analysis. Why?
Because it's like finding out that some enrollees were too old for the test, but got in because their birthdate is wrong. You must exclude them from the data.
The FDA will definitely agree to that, but unfortunately, they may request an additional test to replace the rejected data.
The EMA is more forgiving than the FDA. They will probably approve the vaccine on the condition that further data be collected in the field. Even the FDA may agree to that.
Muddy calculated the p-value and CI from the <33 weeks data and found it to satisfy the FDA's requirements.
So, cheer up. IT WORKS!
Finally, newborns have a line of defence against RSV. And later, it will be proven to work also on older babies, kids and the elderly.
Unfortunately, the market shoots first, and asks questions later. They hear the words "did not meet FDA" and they freak out and sell.
Even after sobering up, many will be worried where the money will come from to deal with a possible setback.
I think the big boys will probably keep the stock down to force Stan to partner or sellout.
NVAX can no longer go it alone. Enough is enough. They developed great vaccines. It's time to hand them over to big pharma, or at least partner with them.
The dust will clear by mid year. Those who are worried now will be comforted by then. Be happy. But, please refrain from excessive excitement (pumping).