This is why I say that I doubt the 3 trials are awaiting announcement of new guidance. If Missling really has made the future planning be dependent on a government body doing certain things at a certain time, I join the posters saying he should be replace as CEO.
No, the trial delays imo are not caused by 5 CNS guidances being announced by Gottleib on a special understanding with Anavex.
Instead the company is working hard to be as confident as can be that data analysis conclusion are valid and the optimum inclusion/exclusion criteria are set for the trials. Better to wait a bit and optimise for success than to go too early and fail.
All of these things come back to money. We want people to live out their lives affordably, then die. Maybe give them a few extra years as long as they don’t break the bank.
So the FDA has their process but we need to speed it up. Like yesterday. No one cares how they do it. The goal is no longer protecting the FDA at all costs. If they don’t serve their purpose someone will find someone who will.
imo
I know how harsh this sounds but what is the alternative? It's happening.
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