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nidan7500

06/11/23 5:54 PM

#418405 RE: Jonjones325 #418402

jonjones

When we see what’s at stake here, you bet you’re axx that we’re in for a fight. That’s why I was perplexed to hear that Missling was going to the fda first.

Didn’t we want to avoid a corrupt system that may be in the hands of BP? It’s disappointing to hear that we won’t go to the TGA first after all their support.



I agree, the sequence and content for (any/all) critical CNS illnesses release by any WW Regulatory body will be major headlines. In this example, FDA has serious process-method questions from the recent BIIB AD -trials which left a serious mark on it's credibility. . M's choice to go with FDA 1st may be a smart strategic move if Dr.M. thinks the FDA is in a swamp and B/C the AVXL data will be robust and not SAME OLE-SAME OLE.... FDA cannot afford to mess this one up in front of a world focused on, and in need of, news that makes sense. IMO, WGT.

tredenwater2

06/11/23 6:01 PM

#418408 RE: Jonjones325 #418402

I guess Missling thinks our data is strong enough to overcome whatever obstacle that may be in our way.



Definitely not something to rush and mess up. Also investors frustrations at our Ceo’s apparent lack of action leads them to believe its due to weakness of results but he has been conveying just the opposite! By waiting and letting the Fda paint themselves into a corner by them approving for a second time a drug with marginal efficacy and horrible safety is one of the strongest moves he can make. It also plays well into the timing of Rett Syndrome approval and the PRV voucher, getting the stock price up for partnership agreement, and gets us that much closer to funding and tightening up all the rials we are getting ready to launch. It wont be hard to become a “mega” revenue rare disease company after Rett Syndrome approval, which is coming!

Keep being “weak” Dr. Missling, palleeeezze!