My list of questions for Tuesday's call. I'm not
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Posted On: 10/18/2020 5:32:10 PM
My list of questions for Tuesday's call. I'm not posting these to elicit comments or answers, I'm posting to encourage you to formulate and submit questions of your own.
General Questions
Has CytoDyn excluded the possibility of any licensing or partnership deals with Big Pharma due to the domestic HIV pricing issue with Vyera disclosed in a recent conference call?
Provide an update on the uplisting effort, and whether or not uplisting is ONLY anticipated to happen after receiving a revenue-generating approval of ANY kind, from ANY country, that will conceivably satisfy multiple NASDAQ listing thresholds.
Provide an update on any Right to Try Act developments.
COVID Questions
Has the FDA seen the CD12 data, and if so, has CytoDyn incurred a P-value penalty, and what exactly was that 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 incentivize and accelerate full enrollment process, or submit the results for approval to other countries?
Provide a COVID submission update for Philippines, EU, Canada, Israel, or Mexico.
Will any new CytoDyn COVID trial protocols include measuring the viral load?
Provide an update on the Moderate protocol?
Provide an update on the Long Hauler protocol?
If the FDA and MHRA have stated that they are not interested in approving leronlimab for moderate COVID patients, why spend money doing a Phase 3 trial?
How exactly is CytoDyn going pay the remaining monies owed to Samsung in 2020 -- as well as fund the Moderate, Long Hauler, and other frequently discussed trials, without an immediate revenue event that is tied to an EUA or approval for a COVID indication?
What is the current enrollment in CD12?
With Dr. Pourhassan repeatedly telling shareholders that an EUA or approval at interim analysis was very unlikely, why did CytoDyn allow the enrollment in the CD12 to slow down after reaching 195 patients – and how exactly will CytoDyn immediately triple the current enrollment rate which will be necessary to achieve full enrollment by the end of the year?
By stating the CytoDyn will enroll the remaining CD12 patients by the end of the year, please confirm that the final readout will not be available until February 2021.
What exactly was the outcome of the UK MHRA UPH Urgent Public Health Submission?
HIV Questions
Is the UK MHRA receptive to reviewing and approving Mono HIV along with Combo HIV?
Has a Combo HIV BLA been submitted to the EU EMA -- and does it include data for Mono approval?
Provide an HIV submission update for Philippines, EU, Canada, Israel, or Mexico.
Which countries, if any, will accept a Mono HIV submission along with the Combo submission for approval.
Cancer Questions
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?
Provide an update on any Breakthrough Therapy Designation developments.
General Questions
Has CytoDyn excluded the possibility of any licensing or partnership deals with Big Pharma due to the domestic HIV pricing issue with Vyera disclosed in a recent conference call?
Provide an update on the uplisting effort, and whether or not uplisting is ONLY anticipated to happen after receiving a revenue-generating approval of ANY kind, from ANY country, that will conceivably satisfy multiple NASDAQ listing thresholds.
Provide an update on any Right to Try Act developments.
COVID Questions
Has the FDA seen the CD12 data, and if so, has CytoDyn incurred a P-value penalty, and what exactly was that 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 incentivize and accelerate full enrollment process, or submit the results for approval to other countries?
Provide a COVID submission update for Philippines, EU, Canada, Israel, or Mexico.
Will any new CytoDyn COVID trial protocols include measuring the viral load?
Provide an update on the Moderate protocol?
Provide an update on the Long Hauler protocol?
If the FDA and MHRA have stated that they are not interested in approving leronlimab for moderate COVID patients, why spend money doing a Phase 3 trial?
How exactly is CytoDyn going pay the remaining monies owed to Samsung in 2020 -- as well as fund the Moderate, Long Hauler, and other frequently discussed trials, without an immediate revenue event that is tied to an EUA or approval for a COVID indication?
What is the current enrollment in CD12?
With Dr. Pourhassan repeatedly telling shareholders that an EUA or approval at interim analysis was very unlikely, why did CytoDyn allow the enrollment in the CD12 to slow down after reaching 195 patients – and how exactly will CytoDyn immediately triple the current enrollment rate which will be necessary to achieve full enrollment by the end of the year?
By stating the CytoDyn will enroll the remaining CD12 patients by the end of the year, please confirm that the final readout will not be available until February 2021.
What exactly was the outcome of the UK MHRA UPH Urgent Public Health Submission?
HIV Questions
Is the UK MHRA receptive to reviewing and approving Mono HIV along with Combo HIV?
Has a Combo HIV BLA been submitted to the EU EMA -- and does it include data for Mono approval?
Provide an HIV submission update for Philippines, EU, Canada, Israel, or Mexico.
Which countries, if any, will accept a Mono HIV submission along with the Combo submission for approval.
Cancer Questions
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?
Provide an update on any Breakthrough Therapy Designation developments.
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