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Posted On: 11/05/2020 5:40:55 PM
Post# of 148902
CYDY CC cliff notes (incomplete)
> 100th repetition of NP’s history lesson of PRO-140 acquisition in 2012
> History lesson of how COVID-19 opportunity came about
> FDA statistician [?] has received unblinded interim data
> Enrollment close to 250 patients; expediting through site visits
> Establishing scientific counsel for COVID-19 by physicians who have treated patients with leronlimab
> Long-hauler protocol submission didn’t happen, debate about PE, modifying protocol, “hopefully” submit to FDA next week: 100 patients, 1:1 randomisation, fast enrolment, since no competition; holding off on Phase 3 moderate; all focus on CD-12
> AMAREX ball-washing
> Dr Rahman’s life-story and work/life balance
> Cancer data results when data come in; 14 patients in basket trial; BTD re-starting talk when they are in; strong results in some patients
Q&A
> CD-12 interim analysis; perhaps not wait 42 days for all patients, ask DSMC
> BLA update: Rahman and Dhody working on it (hiring more staff to help); will announce timelines when Dr Rahman has understanding of the matter; timeline better with UK
> NASDAQ application: potential opportunity is very strong; NASDAQ hasn’t commented back
> CD-12: no shortcut, need to get to next interim point for potential approval
> Discussion with OWS and Dr Woodcock; no guarantee, but possible with (75%) results; billionaire ready to step up with positive data
> HIV monotherapy: meeting to finalize protocol still hasn’t happened; need a clean pivotal Phase 3 trial, UK might be open for it.
> Difficult state laws for Right to Try.
> UK BLA submission: reproductive studies etc. to be done, but might get a waiver; otherwise clear to file.
> Final agreement for HIV cure project in the works; don’t have patient right now, looking for 1 or 2.
> NP doesn’t have a crystal ball to predict SP
> NP thinks that SP should be double-digit; got rid of a lawyer who wanted to take NP’s head off for this comment
> Advantages of leronlimab over other CCR5 antagonists
> Mexico: shocked that they stopped communicating, thank God for America
> Twice: "Arian, can we call the people suing us liars?" "No." (chuckle)
> NP doesn't have a crystal ball to predict SP (chuckle).
> Company will be Gilead x10-100 in two years if successful with cancer
> 100th repetition of NP’s history lesson of PRO-140 acquisition in 2012
> History lesson of how COVID-19 opportunity came about
> FDA statistician [?] has received unblinded interim data
> Enrollment close to 250 patients; expediting through site visits
> Establishing scientific counsel for COVID-19 by physicians who have treated patients with leronlimab
> Long-hauler protocol submission didn’t happen, debate about PE, modifying protocol, “hopefully” submit to FDA next week: 100 patients, 1:1 randomisation, fast enrolment, since no competition; holding off on Phase 3 moderate; all focus on CD-12
> AMAREX ball-washing
> Dr Rahman’s life-story and work/life balance
> Cancer data results when data come in; 14 patients in basket trial; BTD re-starting talk when they are in; strong results in some patients
Q&A
> CD-12 interim analysis; perhaps not wait 42 days for all patients, ask DSMC
> BLA update: Rahman and Dhody working on it (hiring more staff to help); will announce timelines when Dr Rahman has understanding of the matter; timeline better with UK
> NASDAQ application: potential opportunity is very strong; NASDAQ hasn’t commented back
> CD-12: no shortcut, need to get to next interim point for potential approval
> Discussion with OWS and Dr Woodcock; no guarantee, but possible with (75%) results; billionaire ready to step up with positive data
> HIV monotherapy: meeting to finalize protocol still hasn’t happened; need a clean pivotal Phase 3 trial, UK might be open for it.
> Difficult state laws for Right to Try.
> UK BLA submission: reproductive studies etc. to be done, but might get a waiver; otherwise clear to file.
> Final agreement for HIV cure project in the works; don’t have patient right now, looking for 1 or 2.
> NP doesn’t have a crystal ball to predict SP
> NP thinks that SP should be double-digit; got rid of a lawyer who wanted to take NP’s head off for this comment
> Advantages of leronlimab over other CCR5 antagonists
> Mexico: shocked that they stopped communicating, thank God for America
> Twice: "Arian, can we call the people suing us liars?" "No." (chuckle)
> NP doesn't have a crystal ball to predict SP (chuckle).
> Company will be Gilead x10-100 in two years if successful with cancer
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