Rough notes from Q&A: Q: UK Updates? A: Wo
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Posted On: 09/30/2020 1:53:39 PM
Rough notes from
Q&A:
Q: UK Updates?
A:
Working to get 1st pt enrolled
10/22 is CYDY hope for Pre-BLA meeting
Q: Full report for CD10 public
A: Today, see slides from today’s call
Q: CD-12 penalty?
A: No, we don’t plan to take the penalty and thus unblind the results
Hopefull we will get stat sig p-value at interim anlaysis
Q: NASDAQ uplisting … timeline?
A: MM’s fault.
Q: Why should exec be rewarded with additional shares without approvals?
A: Replace CEO (David W. and Michael K. lead effort)
Needed 70M shares to replace CEO according to report
Q: Has company filed lawsuit against CITRON?
A: No
Q: CYDY priority for FDA approval?
A: COVID & HIV
Q: CD12 enrollment?
A: 220
Q: CD12 sites
A: 24 sites are recruiting.
Every site needs to enroll the data to get the 195 interim completed That is why enrollment has decreased.
Will finish enrollment by EOY
Q: BP SAB?
A: SK chooses.
Had a lot of difficulty getting results from lab and ROT.
Q: BP’s article held for publication by NP
A: ???
Q: Interim Analsysis, can
A: DSMB team, 3 members. They conduct the study.
AMAREX, only 1 person gets to see the data.
Dohdy has to tell what type of analysis to do
That person will know stat sig p-value
They will tell FDA hit stat sig p-value
Q: Remaining liability re: Samsung?
A: 11 batches, producing 1.2M vials
Note #10 in 10/12 or 13th
10Q will be filed 10/13
Q: Why should stockholders stay invested in CYDY
A: LL
Same story of how great he/CYDY is
Q: Biz Dev updates?
A:
SK
Working with 11 BP’s in discussions
Working in China, EU, N. Africa
BP is waiting on the data
Q: Submitted EIND data to MHRA
A: Not yet, should be ready in a couple fo weeks
Q: CD12 results?
A: Immediately when interim is available
Q: Mfg
A: Over 30k vials, ~50k vials
300K vials will be shipped in the next two week
900k will not do fill and finish until know approvals
Q: Hiring
A:
Q: Details of pts for COMBO
A: MDR, 3-class resistance
Dr. Maddon, we get 2-class resistance
240k pt population in US
1-3B market
5-6B market for MONO
Q: Priority review COMBO
A: Priority will be given after BLA is submitted
Q: Cash & Burn
A:
MM don’t report interim
10k, May 31, $14.3M
Since June 1, raised $46M
$21 from warrants and options
and closing on convertible note
Q: BLA
A:
ROT was a failure
CD03 – need all data
Will submit CD03 to UK
Q: Does AMAREX have sufficient resource to handle all the trials?
A: Need to bring in another CRO
Q: NIH MX
A: Have not heard back from MX
Q: Indications CYDY approved within 3yrs
A: “Tremendous”
SK: Building a strong foundation
Just need to get 1st approval.
Q: CTC, CAML data
A: Working with Creative Mirco to get this data
Q: BP to expedite approvals
A: Difficult for any BP to take all of CYDY
Q:
A: 100% approvable drug
Q: Better PR?
A: Comes when lives are being saved.
Have hired or fired 20 pr groups
Q: Can provide DSMB data to other countries without incurring the p-value penalty
A: No
Q: Where is the ~45 deaths in CD12 come from?
A: Now number is 50 deaths
2:1 randomized
Q: Do we know which basket the deaths are in?
A: NO
Q: REM approved and Regeneron might approved for M2M
A: REM didn’t do a study in M2M
REM has EUA, but not approval, for “moderate and hospitalized”
Q: LH protocol
A: Synopsis is almost finalized. Will send as soon as it is ready to go.
SK: 75% pts hospitalized become LH
Q: Why not P3 for LH
A: Don’t know for sure how LL will work with LH?
Q: UK MHRA UPHS?
A: Excellent meeting
They want early access use
Want to see EIND data
Q: After BLA submitted, time intervals?
A: We have rolling review for BLA
March 2019, hopefully been reviewed
Mfg hopefully reviewed
Hope that some of those timelines will be compressed
Q: BTD for scheduled for SEpt
A: Creative Micro
Once the analysis is ready, will go to FDA
Q?
Q: 700mg Basket Trial
A: Still going with 525, still awaiting FDA decision
CYDY_Team@cytodyn.com
Q&A:
Q: UK Updates?
A:
Working to get 1st pt enrolled
10/22 is CYDY hope for Pre-BLA meeting
Q: Full report for CD10 public
A: Today, see slides from today’s call
Q: CD-12 penalty?
A: No, we don’t plan to take the penalty and thus unblind the results
Hopefull we will get stat sig p-value at interim anlaysis
Q: NASDAQ uplisting … timeline?
A: MM’s fault.
Q: Why should exec be rewarded with additional shares without approvals?
A: Replace CEO (David W. and Michael K. lead effort)
Needed 70M shares to replace CEO according to report
Q: Has company filed lawsuit against CITRON?
A: No
Q: CYDY priority for FDA approval?
A: COVID & HIV
Q: CD12 enrollment?
A: 220
Q: CD12 sites
A: 24 sites are recruiting.
Every site needs to enroll the data to get the 195 interim completed That is why enrollment has decreased.
Will finish enrollment by EOY
Q: BP SAB?
A: SK chooses.
Had a lot of difficulty getting results from lab and ROT.
Q: BP’s article held for publication by NP
A: ???
Q: Interim Analsysis, can
A: DSMB team, 3 members. They conduct the study.
AMAREX, only 1 person gets to see the data.
Dohdy has to tell what type of analysis to do
That person will know stat sig p-value
They will tell FDA hit stat sig p-value
Q: Remaining liability re: Samsung?
A: 11 batches, producing 1.2M vials
Note #10 in 10/12 or 13th
10Q will be filed 10/13
Q: Why should stockholders stay invested in CYDY
A: LL
Same story of how great he/CYDY is
Q: Biz Dev updates?
A:
SK
Working with 11 BP’s in discussions
Working in China, EU, N. Africa
BP is waiting on the data
Q: Submitted EIND data to MHRA
A: Not yet, should be ready in a couple fo weeks
Q: CD12 results?
A: Immediately when interim is available
Q: Mfg
A: Over 30k vials, ~50k vials
300K vials will be shipped in the next two week
900k will not do fill and finish until know approvals
Q: Hiring
A:
Q: Details of pts for COMBO
A: MDR, 3-class resistance
Dr. Maddon, we get 2-class resistance
240k pt population in US
1-3B market
5-6B market for MONO
Q: Priority review COMBO
A: Priority will be given after BLA is submitted
Q: Cash & Burn
A:
MM don’t report interim
10k, May 31, $14.3M
Since June 1, raised $46M
$21 from warrants and options
and closing on convertible note
Q: BLA
A:
ROT was a failure
CD03 – need all data
Will submit CD03 to UK
Q: Does AMAREX have sufficient resource to handle all the trials?
A: Need to bring in another CRO
Q: NIH MX
A: Have not heard back from MX
Q: Indications CYDY approved within 3yrs
A: “Tremendous”
SK: Building a strong foundation
Just need to get 1st approval.
Q: CTC, CAML data
A: Working with Creative Mirco to get this data
Q: BP to expedite approvals
A: Difficult for any BP to take all of CYDY
Q:
A: 100% approvable drug
Q: Better PR?
A: Comes when lives are being saved.
Have hired or fired 20 pr groups
Q: Can provide DSMB data to other countries without incurring the p-value penalty
A: No
Q: Where is the ~45 deaths in CD12 come from?
A: Now number is 50 deaths
2:1 randomized
Q: Do we know which basket the deaths are in?
A: NO
Q: REM approved and Regeneron might approved for M2M
A: REM didn’t do a study in M2M
REM has EUA, but not approval, for “moderate and hospitalized”
Q: LH protocol
A: Synopsis is almost finalized. Will send as soon as it is ready to go.
SK: 75% pts hospitalized become LH
Q: Why not P3 for LH
A: Don’t know for sure how LL will work with LH?
Q: UK MHRA UPHS?
A: Excellent meeting
They want early access use
Want to see EIND data
Q: After BLA submitted, time intervals?
A: We have rolling review for BLA
March 2019, hopefully been reviewed
Mfg hopefully reviewed
Hope that some of those timelines will be compressed
Q: BTD for scheduled for SEpt
A: Creative Micro
Once the analysis is ready, will go to FDA
Q?
Q: 700mg Basket Trial
A: Still going with 525, still awaiting FDA decision
CYDY_Team@cytodyn.com
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