Kun Jin's hiring and choosing to stay is not only great because of what he brings to the company but also what it says indirectly.
It says, Missling's statements about meeting endpoints are valid. Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL
It says, the data is valid and no manipulation or fudging occurred. It says the Odds Ratio was in the SAP although it may not have been the best presentation of the results. Kun will fix that.
It says, Missling really is pursuing an accelerated approval and that it IS possible to achieve. Otherwise, Jin would have been like. Dude, why did you say that? I guess he could have but not likely. Missling has said the same in every presentation after the CTAD.
It says, he is confident enough to have this represent the finale to his career.
It says the Excellence data will be in good hands and the statistical aspects of our NDA will be proper.
It says Missling knows he needs help and is willing to seek the right people. Look at our SAB. He's always known that he needs to surround himself with the best.
I believe Kun is looking at the PDD OLE before its release, hence the delay. Hopefully he will also, as others have suggested, try to tie this in with our Alz data to make a more convincing package. I'm not smart enough to figure out how or even if that can work.
I must admit, my frustration level with Missling was at an all time high before the Kun hire. It's still high now, but I feel better knowing the above.
Kun has connections at the FDA. Those don't go away because Billy did. I wonder if he has connections to his counterparts at the EMA and TGA. I'm betting he does in some capacity, even name recognition matters to a degree.
How may BPs are our new PR guy networking with? How many feel threatened by our CNS Platform? How many have dwindling CNS divisions that need innovation? How many want a piece?
Kun was part of the status quo that was indirectly supporting the amyloid hypothesis. He just broke away.
It takes balls to come to a tiny, virtually unknown biotech with a new paradigm shifting MOA.
Soooon!!
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