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NDR Group

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In the great effort to bring treatments to ALS patients Richard funded a clinical trial for FC-12738. This molecule is novel (Richard and I called it TVALA)...the world has never seen it before! It engages the failing immune system and will (hopefully) RESET an ALS patient's ability to normalize neuroinflammation—slowing disease and allowing doctors to stack additional life-saving therapies as patients change over the course of their illness.

The down side...the world has never seen this molecule before! The ever cautious FDA wants us to dose some normal folk before we go after saving ALS patients. Richard's Study enrolls 2 people (one dosed and one not, they are called sentinels) and if no one is adversely affected, and they are still alive after 8 days, we can then dose 6 additional normal people (at the same dose). We are happily reporting no adverse events after 8 folk got 4 mg and 8 folk got 8 mg. The sentinel normal's got 16 mg last week and on May 31, fingers crossed, the six additional people will be dosed. After 8 days we will send the data to FDA and get to what Richard really new drug to get into clinical trial for ALS patients.

This photo is when Richard was talking to me about his provisional diagnosis, it was in 2019. He took a selfie and joked about jumping...he almost went over the rail so we had a good laugh!!


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