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kund

01/21/25 8:49 PM

#481264 RE: baltimorebullet #481255

FDA signed off

are you joking? Misleading never had any communication with FDA on any of the trial, guy was telling lies for last 10year.
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Investor2014

01/22/25 4:57 AM

#481271 RE: baltimorebullet #481255

So many misconceptions - be investors, which means take a step back, do the research on how things actually work, keep an open mind plus be a bit sceptical. It helps.

FDA signed off - no. 58 peer reviewers - no. etc. etc.
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Hoskuld

01/22/25 10:50 AM

#481280 RE: baltimorebullet #481255

Baltimore, the FDA will pretty much let you do anything you want as long as patients are not being harmed. They won't make business decisions for you, such as telling you how to power your trial. If you ask questions then of course they will give an opinion. FWIW, when I called to ask Anavex why the trials were uniformly too small, the response was that they were not sure 2-73 would work so didn't invest more. That was a little upsetting because I invested because I believed I was placing a bet on something they had full confidence in - and their holding back created more and not less risk for my investment. I think they believe in themselves now and are changing their approach (as seen by their increasing the 3-71 trial size.)