Monday, May 22, 2023 3:07:09 PM
1. Given the overall success of the pipeline and zero failed trials to date, why hasn't Wall St. given the company a proper valuation and why hasn't the true biotech institutional investors shared your excitement and bought shares of the company?
2. Can you please explain why you did not go for approval for Rett adult population which basically slowed down the time to market by over a year having to wait for the pediatric study to end. Why didn't you complete both trials at the same time? If this took place the drug might be on the market today.
3. Can you please let us know if the confirmatory trial being run for Alzheimer's will be a P3 placebo trial or a P4 trial with no placebo?
4. The surrogate biomarkers that the company is trying to gain accelerated approval for is A-Beta and Tau. Did we remove this plaque at the same levels that Biogen and Lilly reported. Is Blarcamisine more effective than their drugs in doing this?
5. When will you be meeting with the FDA and the other agencies around the world to discuss Accelerated Approval?
6. In what timeframe to you envision an NDA to any agency for approval of Blarcamisine? Since you stated that you are ready for commercialization how far down the path is the company with gaining approvals knowing that Accelerated Approval allows for more meetings and submission of data as you receive it instead of waiting for all data to be packaged? Are you weeks away from submission, months of an NDA for any region?
7. Why take the strategy of promising a lot but not delivering in a timely fashion? The company never hits its self imposed timeframes.
8. What do you envision the headcount to be by the end of the year and if things go as planned where do you see headcount end of next year?
9. Why no insider purchases to help protect the stock and shareholders?
10. What is the status of partnering? If you are approved for Accelerated Approval I would think that a partner would need to be completed soon. Do you see a partnership this year?
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