MGK_2
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9h ago
"Montefiore’s Neuro Bet: Beyond oncology, the Einstein/Montefiore preclinicals (March 2024) and Cornell’s Alzheimer’s pilot (December 2024) hint at CCR5’s brain inflammation role. A neurodegeneration win’s a $50B market—CYDY’s dark pool."
"27:15 Nader: Yeah, and BTD that we will be filing, Dr. Nitya Ray did a fantastic job on that. There were some patients with brain metastases*. Dr. Ray, explain to us, for a breakthrough designation strategy, are* we going to file for brain metastases and perhaps later on, if we do get BTD on the original submissions, maybe we want to ask for Basket Trial data, but tell us about the Basket Trial please.
27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases*. They are* all mTNBC patients*. So we have submitted all of the results,* including all of the patients with brain metastases*, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and* see that forward with brain metastases*. Now,* these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases."