Okay, the questions we sent NP Thursday (at the b
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Posted On: 07/30/2019 11:26:22 AM
Okay, the questions we sent NP Thursday (at the bottom) before everything.
Here are three questions I PMed IslayScotchWhiskey about IP/RP. He got a lot of good info. Maybe questions that were not answered. The last one is still good. I am going out the door right now, but will be back in a couple hours. I will think while I'm out. Maybe others can chime in.
Combo/BLA
BLA submission timeline with 525mg vs 700mg? (specifically how if 700mg is needed the timeline would change)
Anticipation date FDA will give final safety data requirements?
When will the 700mg safety data with the 100 patients be complete?
Mono
Update on FDA meeting date? (Anticipated date for meeting?)
TNBC (maybe RP can comment also)
Recruiting status on the open TNBC site? Patients screened yet?
Any update on your investigation into the TNBC trial delays?
Updates on remaining sites opening? IRB approval for these yet?
Remaining (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:
Updates on Prognostic test license? Is this pending 510(k) FDA decision?
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?
Other:
Impacts of Dr. Rae (Business Development) so far?
How does he plan to increase share price?
Here are three questions I PMed IslayScotchWhiskey about IP/RP. He got a lot of good info. Maybe questions that were not answered. The last one is still good. I am going out the door right now, but will be back in a couple hours. I will think while I'm out. Maybe others can chime in.
Quote:
Why is the ProstaGene IP patents still in RP’s name?
Will RP fight the transfer?
Without RP, how are they going to handle the face-to-face meeting in August to discuss CytoDyn’s 510(k) application for ProstaGene™ Prognostic Test?
Combo/BLA
BLA submission timeline with 525mg vs 700mg? (specifically how if 700mg is needed the timeline would change)
Anticipation date FDA will give final safety data requirements?
When will the 700mg safety data with the 100 patients be complete?
Mono
Update on FDA meeting date? (Anticipated date for meeting?)
TNBC (maybe RP can comment also)
Recruiting status on the open TNBC site? Patients screened yet?
Any update on your investigation into the TNBC trial delays?
Updates on remaining sites opening? IRB approval for these yet?
Remaining (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:
Updates on Prognostic test license? Is this pending 510(k) FDA decision?
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?
Other:
Impacts of Dr. Rae (Business Development) so far?
How does he plan to increase share price?
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(0)CytoDyn Inc (CYDY) Stock Research Links
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