Some tidbits from April 6 CC: - EUA from FDA se
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Posted On: 04/08/2021 3:29:50 PM
Some tidbits from April 6 CC:
- EUA from FDA seems to have several pathways. No need to repeat all, but bottom line is a bit more data in one of several forms could complete CD-12 and then it is a done deal based on results to date.
- April 15th is submittal date for Interim Order Package to Canada. Post this, if Cytodyn does a trial in Canada, it maybe possible to begin sales immediately.
- Philippines, in addition to ONE hospital ordering 28 compassionate doses, they have received a non-binding order for 100,000 more doses. Terms are being worked out.
- Brazil is cooking !!
- NEXT CC IN TWO WEEKS, TOPICS MENTIONED:
* Cancer basket trial, 9 patients stage 4 still alive, results to be submitted for a pre BTD meeting with the FDA. Could be huge!
* Long Hauler trial is completed, PR shortly, TAM is 20M to 60M and growing. Very exciting!!
* NASH update (?)
* HIV BLA progress (?)
* Lots of interest being shown on working with Cytodyn on for trials, etc..
- Regarding discussions with big pharma or others:
* "Cannot comment on ACTIVE discussions!!" So are there any ACTIVE discussions? Unclear .... My read is that the moment they have an EUA, they will be inundated with interest.
- EUA from FDA seems to have several pathways. No need to repeat all, but bottom line is a bit more data in one of several forms could complete CD-12 and then it is a done deal based on results to date.
- April 15th is submittal date for Interim Order Package to Canada. Post this, if Cytodyn does a trial in Canada, it maybe possible to begin sales immediately.
- Philippines, in addition to ONE hospital ordering 28 compassionate doses, they have received a non-binding order for 100,000 more doses. Terms are being worked out.
- Brazil is cooking !!
- NEXT CC IN TWO WEEKS, TOPICS MENTIONED:
* Cancer basket trial, 9 patients stage 4 still alive, results to be submitted for a pre BTD meeting with the FDA. Could be huge!
* Long Hauler trial is completed, PR shortly, TAM is 20M to 60M and growing. Very exciting!!
* NASH update (?)
* HIV BLA progress (?)
* Lots of interest being shown on working with Cytodyn on for trials, etc..
- Regarding discussions with big pharma or others:
* "Cannot comment on ACTIVE discussions!!" So are there any ACTIVE discussions? Unclear .... My read is that the moment they have an EUA, they will be inundated with interest.
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