Okay, here is why I have so far. Let me know if I
Post# of 155539
(Total Views: 297)
Posted On: 07/11/2019 2:28:13 PM
Okay, here is why I have so far. Let me know if I missed any.
Combo/BLA
Anticipation date FDA will give final safety data requirements?
Any response from FDA to our first part of BLA
BLA submission timeline with 525mg vs 700mg?
Did the early discontinues in the placebo arm happen before steady-state? (pvalue for completed between groups <.02)
Why not send BLA Part 3 for FDA to review why we wait on safety data for Part 2?
Mono
Update on FDA meeting date?
Will new protocol include dose based on ccr5 density?
Will the primary endpoint measure only maintenance phase efficacy?
TNBC
Updates on remaining sites opening? IRB approval for these yet?
Recruiting status on the open TNBC site? Patients screened yet?
Given delays, is managment still optimistic about the trial?
Any update on your investigation into the TNBC trial delays?
GvHD, Cancer, NASH, MS
Status updates: GvHD enrollment, NASH study, any of the 8 cancer pre-clinical trials started, Colon Cancer IND, MS plans.
Financing / License Agreement / Partnerships:
Expected amount to raise from current TO?
Do they expect to extend or re-open the TO in the future?
Updates on commercialization pharma company agreement related to HIV and GVHD? Or does CYDY expect to commercialize Leronlimab?
Terms discussed in non-binding term sheet that was verbally accepted pending BOD approval from China investment?
Any progression in Samsung capital investment?
Updates on mid-tier pharma partnership?
Updates on Prognostic test license? Is this pending 510(k) FDA decision?
Do you still plan to win your $5 share price bet and if so how?
Other:
Expected release date for Dr. Sacha HIV/Leronlimab research results?
Impacts of Dr. Rae (Business Development) so far?
How does he plan to increase share price?
Details on up-list plan (RS....no based on previous comments; what we can expect to meet the requirements)?
Combo/BLA
Anticipation date FDA will give final safety data requirements?
Any response from FDA to our first part of BLA
BLA submission timeline with 525mg vs 700mg?
Did the early discontinues in the placebo arm happen before steady-state? (pvalue for completed between groups <.02)
Why not send BLA Part 3 for FDA to review why we wait on safety data for Part 2?
Mono
Update on FDA meeting date?
Will new protocol include dose based on ccr5 density?
Will the primary endpoint measure only maintenance phase efficacy?
TNBC
Updates on remaining sites opening? IRB approval for these yet?
Recruiting status on the open TNBC site? Patients screened yet?
Given delays, is managment still optimistic about the trial?
Any update on your investigation into the TNBC trial delays?
GvHD, Cancer, NASH, MS
Status updates: GvHD enrollment, NASH study, any of the 8 cancer pre-clinical trials started, Colon Cancer IND, MS plans.
Financing / License Agreement / Partnerships:
Expected amount to raise from current TO?
Do they expect to extend or re-open the TO in the future?
Updates on commercialization pharma company agreement related to HIV and GVHD? Or does CYDY expect to commercialize Leronlimab?
Terms discussed in non-binding term sheet that was verbally accepted pending BOD approval from China investment?
Any progression in Samsung capital investment?
Updates on mid-tier pharma partnership?
Updates on Prognostic test license? Is this pending 510(k) FDA decision?
Do you still plan to win your $5 share price bet and if so how?
Other:
Expected release date for Dr. Sacha HIV/Leronlimab research results?
Impacts of Dr. Rae (Business Development) so far?
How does he plan to increase share price?
Details on up-list plan (RS....no based on previous comments; what we can expect to meet the requirements)?
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