Tuesday, August 09, 2022 6:20:46 PM
I especially like the parts you bolded:
"Additionally I'd like to make mention that we have adequate manufacturing and supply in place for a rollout assuming approval and commercialization"
Q: Can you speak to the imaging use of Blarcamesine vs. therapeutic use at a commercialization level? Also, how are you thinking of optimizing the value of Blarcamesine in U.S. territories. Can we talk about partnerships? Please also add context regarding IP protection in places such as China?
A: We did notice in all three indications that S1R shows up in two different genetic forms (WT [80-90%] vs. mutation) and WT had better results. With high enough dosing however, there is not much difference between WT and mutation. We are in parallel developing a diagnostic test in order to go into the market with the ability to identify WT-gene patients if necessary. We will see if the AD and EXCELLENCE study will require such a selection. It may be that there is enough benefit in both S1R-gene groups that we don’t need such a diagnostic but will have it just in case. We are planning on marketing Rett syndrome and possibly Fragile-X ourselves. We are in discussions with European, Asian, and Chinese companies to market outside the U.S. We are also looking at global partnerships and regional partnership opportunities. We ARE in discussions for this already for a worldwide roll-out. We have filed patents to become aggressive with protection in China – always including protection in the U.S., Europe, and Asia, with specifically in China.
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