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Posted On: 06/23/2020 8:40:16 AM
Post# of 148945
Exciting days ahead for sure. Regarding the 22 cancer “basket” approval, would appreciate some clarity on what the FDA granted Cytodyn?
Here are some questions:
- Is objective to get BTD for entire basket of cancer types? If not, what is the objective, gathering data to determine next steps?
- does Cytodyn file a single protocol for all 22 cancer types? Or do they file, one time, 22 protocols, one for each cancer type.
- Have they filed the needed protocols?
- Approx duration of each patients treatment?
- CTC amount measured be the primary end point?
- when a patient applies to Cytodyn for treatment and gets qualified, does the FDA have to be notified and do they have to approve?
- How many patients can they treat under this approval?
- When do they file the results with the FDA, per patient, per cancer type?
Here are some questions:
- Is objective to get BTD for entire basket of cancer types? If not, what is the objective, gathering data to determine next steps?
- does Cytodyn file a single protocol for all 22 cancer types? Or do they file, one time, 22 protocols, one for each cancer type.
- Have they filed the needed protocols?
- Approx duration of each patients treatment?
- CTC amount measured be the primary end point?
- when a patient applies to Cytodyn for treatment and gets qualified, does the FDA have to be notified and do they have to approve?
- How many patients can they treat under this approval?
- When do they file the results with the FDA, per patient, per cancer type?
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