This is what we were doing 3 years ago:
CytoDyn updates on submission of CMC to FDA for HIV Biologics License Application
"CC: And now moving onto Oncology, we did say recently, that Health Canada did authorize the Emergency Use of your Drug to treat patients with metastatic Triple Negative Breast Cancer. What are the next steps here? and Tell us about your other Oncology Programs.
Nader: So the mTNBC, 10 out of 28 patients data that were submitted, were out of our Phase 1B-2. That was a dosage study. FDA requires dosage study for BTD also. We have that 1 part of the data. Clearly shows that 700mg was better. Which is what FDA would like to see. The other 18 patients were the Compassionate Use, but keep in mind that these 28, if you divide it by 2 groups, 1 group had CC, circulating cells, which is a marker, blood test they take and its a marker that when they looked at it, that when CC went lower, the group in Leronlimab when CC went lower, had 3,600% which is 36 times better than the other group of Leronlimab. Together, we were as good or better than the SOC, whether it was Overall Survival, OS, or Progression Free Survival. So now we have very exciting data. We submitted that to the FDA on November 5. We hope to get answer this month. We have FTD that FDA granted us for mTNBC and we also told the public that we will be filing other BTD.
For example, 7 patients with mets to brain, are surviving quite a while. And usually, the survival rate is only 3-4 months. And we have patients going 2 years now. 2 years with metastasis to the brain. So, that's a BTD coming up.
But, we would like to get this first one to see how the agency feels and the agency already told us, they immediately sent us a letter, and said that, keep in mind, that if we give you BTD, you need to file for Expanded Access within 15 days of receiving approval of BTD , if we get it.
And we are filing Expanded Access and again, our 1st patient in Canada, got EUA, one patient, so we can sell for 6 months, product to them. And we are talking to a pharmaceutical over there right now. Be very excited to get a licensing deal there. They want to start selling with that same kind of Compassionate Use and perhaps get the product registered."
CytoDyn updates on submission of CMC to FDA for HIV Biologics License Application
"CC: And now moving onto Oncology, we did say recently, that Health Canada did authorize the Emergency Use of your Drug to treat patients with metastatic Triple Negative Breast Cancer. What are the next steps here? and Tell us about your other Oncology Programs.
Nader: So the mTNBC, 10 out of 28 patients data that were submitted, were out of our Phase 1B-2. That was a dosage study. FDA requires dosage study for BTD also. We have that 1 part of the data. Clearly shows that 700mg was better. Which is what FDA would like to see. The other 18 patients were the Compassionate Use, but keep in mind that these 28, if you divide it by 2 groups, 1 group had CC, circulating cells, which is a marker, blood test they take and its a marker that when they looked at it, that when CC went lower, the group in Leronlimab when CC went lower, had 3,600% which is 36 times better than the other group of Leronlimab. Together, we were as good or better than the SOC, whether it was Overall Survival, OS, or Progression Free Survival. So now we have very exciting data. We submitted that to the FDA on November 5. We hope to get answer this month. We have FTD that FDA granted us for mTNBC and we also told the public that we will be filing other BTD.
For example, 7 patients with mets to brain, are surviving quite a while. And usually, the survival rate is only 3-4 months. And we have patients going 2 years now. 2 years with metastasis to the brain. So, that's a BTD coming up.
But, we would like to get this first one to see how the agency feels and the agency already told us, they immediately sent us a letter, and said that, keep in mind, that if we give you BTD, you need to file for Expanded Access within 15 days of receiving approval of BTD , if we get it.
And we are filing Expanded Access and again, our 1st patient in Canada, got EUA, one patient, so we can sell for 6 months, product to them. And we are talking to a pharmaceutical over there right now. Be very excited to get a licensing deal there. They want to start selling with that same kind of Compassionate Use and perhaps get the product registered."
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