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Posted On: 09/29/2020 9:35:33 PM
Post# of 148899
I banged out a quick list of questions that I am emailing to CytoDyn for tomorrow's call.
Importantly, I am not listing them here in order to solicit your answers or arguments (I don't want your responses).
I am listing them to encourage you to think of your own questions and present them before Wednesday @ 8am PT.
General Questions
Has CytoDyn excluded the possibility of any licensing or partnerships with Big Pharma due to the pricing issue with Vyera disclosed in a recent conference call?
Provide an update on product quantities received to date from Samsung and AGC, and quantities projected for the remaining months of 2020.
Provide an update on the uplisting effort – and if uplisting is only anticipated to happen after receiving an approval from any country in order to support the price above NASDAQ thresholds.
COVID Questions
Is there any available mechanism to provide the still-blinded DSMC data from the interim CD12 to other countries for approval without incurring the P-Value penalty?
If CytoDyn does not have visibility on the blinded DSMC data, how can it decide to accept the interim CD12 P-Value penalty in order to submit the results for approval to other countries?
Provide a COVID submission update on Mexico, EU, Canada, Philippines, and Israel.
Will any new CytoDyn COVID trial protocol include measuring the viral load like regeneron?
Dr. Pourhassan has incorrectly stated in two conference calls that no other drug has received approval for the moderate COVID population -- remdesivir has already been approved for that population. And regeneron will likely also be approved for the same population. Please explain how the FDA told CytdoDyn that they have no interest in approving leronlimab for this population.
If the FDA has no interest in approving leronlimab for the moderate population in COVID, why bother doing a Phase 3 trial?
Has the FDA accepted the Long Hauler protocol?
Why isn’t the Long Hauler trial a Phase 3?
What is the current enrollment in CD12?
Why did CytoDyn allow the enrollment in the CD12 to slow down – and what exactly will be done to accelerate the enrollment rate?
What was the outcome of the UK MHRA UPH Urgent Public Health Submission?
HIV Questions
Will the BLA submitted to the UK MHRA include data for Mono approval?
Has a Combo HIV BLA been submitted to the EU EMA -- and does it include data for Mono approval?
Provide an HIV submission update on Mexico, EU, Canada, Philippines, and Israel.
Which countries, if any, will accept a Mono HIV submission along with the Combo submission for approval.
Once the US FDA Combo HIV BLA is resubmitted, will CytoDyn need to wait 60 days for a RTF and 74 days for an official BLA acceptance and PDUFA date – or can any of those time intervals be compressed?
Cancer Questions
Provide an update on the Breakthrough Therapy Designation meeting with the FDA that was scheduled for September.
Provide an update on Dr. Jay Lalezari’s request to the FDA for increasing the Basket Trial dose to 700mg.
What is the status of the Creative Microtechnology analysis of Basket Trial for BTD?
Importantly, I am not listing them here in order to solicit your answers or arguments (I don't want your responses).
I am listing them to encourage you to think of your own questions and present them before Wednesday @ 8am PT.
Quote:
In light of the limited amount of time for the meeting, stockholders are also encouraged to submit questions to management before 8:00 am PT tomorrow to: CYDY_team@cytodyn.com.
General Questions
Has CytoDyn excluded the possibility of any licensing or partnerships with Big Pharma due to the pricing issue with Vyera disclosed in a recent conference call?
Provide an update on product quantities received to date from Samsung and AGC, and quantities projected for the remaining months of 2020.
Provide an update on the uplisting effort – and if uplisting is only anticipated to happen after receiving an approval from any country in order to support the price above NASDAQ thresholds.
COVID Questions
Is there any available mechanism to provide the still-blinded DSMC data from the interim CD12 to other countries for approval without incurring the P-Value penalty?
If CytoDyn does not have visibility on the blinded DSMC data, how can it decide to accept the interim CD12 P-Value penalty in order to submit the results for approval to other countries?
Provide a COVID submission update on Mexico, EU, Canada, Philippines, and Israel.
Will any new CytoDyn COVID trial protocol include measuring the viral load like regeneron?
Dr. Pourhassan has incorrectly stated in two conference calls that no other drug has received approval for the moderate COVID population -- remdesivir has already been approved for that population. And regeneron will likely also be approved for the same population. Please explain how the FDA told CytdoDyn that they have no interest in approving leronlimab for this population.
If the FDA has no interest in approving leronlimab for the moderate population in COVID, why bother doing a Phase 3 trial?
Has the FDA accepted the Long Hauler protocol?
Why isn’t the Long Hauler trial a Phase 3?
What is the current enrollment in CD12?
Why did CytoDyn allow the enrollment in the CD12 to slow down – and what exactly will be done to accelerate the enrollment rate?
What was the outcome of the UK MHRA UPH Urgent Public Health Submission?
HIV Questions
Will the BLA submitted to the UK MHRA include data for Mono approval?
Has a Combo HIV BLA been submitted to the EU EMA -- and does it include data for Mono approval?
Provide an HIV submission update on Mexico, EU, Canada, Philippines, and Israel.
Which countries, if any, will accept a Mono HIV submission along with the Combo submission for approval.
Once the US FDA Combo HIV BLA is resubmitted, will CytoDyn need to wait 60 days for a RTF and 74 days for an official BLA acceptance and PDUFA date – or can any of those time intervals be compressed?
Cancer Questions
Provide an update on the Breakthrough Therapy Designation meeting with the FDA that was scheduled for September.
Provide an update on Dr. Jay Lalezari’s request to the FDA for increasing the Basket Trial dose to 700mg.
What is the status of the Creative Microtechnology analysis of Basket Trial for BTD?
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