What does Missling know? What are the regulators telling him? We are so focused on the FDA and sometimes forget that PDD and Alz are not US trials. I believe we answer to the bodies where are trials are registered and that’s where our first applications will be.
Yes, Missling is hiring marketing and sales positions indicating he feels like we are close. Would he hire these positions if we were a year out? Probably not good to have employees sitting around doing nothing waiting on the possibility. Let alone the possibility of losing a job that you haven’t even started yet.
Many have said before, that getting Rett approved first will help pave the way for a more favorable Alz decision if good data. Getting anything approved for that matter, anywhere. It will be a big blow if we are required to do another Alz trial. Missling of course knows this and I believe there’s a plan here. Wish we didn’t have to speculate so much. Missling has never surprised us with a move. Maybe this time will be different.
PDD is difficult to ignore with such great results. Complete silence, no complete data given - actigraphy, etc. No peer review. So strange. Does Missling just let it sit in the back burner and say let’s just plan a phase 3 after we see the OLE data? Or does he say, after we get the confirmatory OLE data, we’ll send a complete package to apply for whatever we can get. My guess is the latter. Game changing data deserves game changing moves and urgency.
Given what we have seen, any CEO would make this a top priority. Missling is juggling many things. Rett, Alz and PDD is keeping him busy enough. No wonder the fragile x and Parkinson’s imaging trials are being pushed back. It’s definitely why he’s hiring. He’s finally saying, damn, this is way too much. Need help to get all these very important priorities moving.
So he hires when it’s needed. What is telling him a marketing team is needed?
We should have a very productive 2nd half.
