Re: GvHD
A couple of observations from which everyone may form his or her own opinion on this matter:
(1) Mid-October investor presentation states they plan to enroll 5 patients in 2020 to apply for BTD (that can be explained by NP's over-zealous nature and his trying to pump up investors at any opportunity, because who could have known that they couldn't enroll during pandemic)
(2) We don't know the status of the patient(s) enrolled in Spring (but NP has a tendency to report anecdotal results if they are positive; for GvHD he just praises the animal data)
(3) During Nov CC, NP stated that he wouldn't comment on GvHD until Mahoob has been updated and seen the data, all while saying GvHD is on the back-seat currently (about 53:50-54:30)
(4) The trial has been open for years (protocol has been modified this year; we weren't ever given a clear rationale nor have the results of the 10 patients enrolled under the old, placebo-controlled protocol ever been announced). Question her is: why close it down completely if you can just pause it (like they apparently did for the bulk of the last 3 years)?
(5) NP doesn't like to PR unfavourable news; for instance, he also pulled the stunt of burrying the BLA submission delay (missing data set) deep in the sub-text of a PR.
(6) As ohm already posted, GvHD enrollment, esp during this environment, is particularly challenging.
(7) Here is what CYDY disclosed in the previous filings:
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I'm not particularly interested in the many mysteries of the GvHD trial and its never-ending story at the moment, given that CD-12 readout is so close, but I will definitely dig into this more if we don't get a very favourable PR in January aka "Primary endpoint met". And I won't be satisfied with a PR trying to hide this news which contradicts the guidance given during previous presentations 6-8 weeks ago.
A couple of observations from which everyone may form his or her own opinion on this matter:
(1) Mid-October investor presentation states they plan to enroll 5 patients in 2020 to apply for BTD (that can be explained by NP's over-zealous nature and his trying to pump up investors at any opportunity, because who could have known that they couldn't enroll during pandemic)
(2) We don't know the status of the patient(s) enrolled in Spring (but NP has a tendency to report anecdotal results if they are positive; for GvHD he just praises the animal data)
(3) During Nov CC, NP stated that he wouldn't comment on GvHD until Mahoob has been updated and seen the data, all while saying GvHD is on the back-seat currently (about 53:50-54:30)
(4) The trial has been open for years (protocol has been modified this year; we weren't ever given a clear rationale nor have the results of the 10 patients enrolled under the old, placebo-controlled protocol ever been announced). Question her is: why close it down completely if you can just pause it (like they apparently did for the bulk of the last 3 years)?
(5) NP doesn't like to PR unfavourable news; for instance, he also pulled the stunt of burrying the BLA submission delay (missing data set) deep in the sub-text of a PR.
(6) As ohm already posted, GvHD enrollment, esp during this environment, is particularly challenging.
(7) Here is what CYDY disclosed in the previous filings:
Quote:Phase 2 Trial for Graft-versus-Host Disease
This Phase 2 multi-center 100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab as anadd-on therapy to
standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with AML or MDS undergoing allogeneic hematopoietic stem cell
transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, we announced that the FDA had granted
orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring
Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients
enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, we filed amendments to the protocol with the FDA. The amendments
included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning
(“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive
leronlimab. The amendments also provide for a 100% increase in the dose of leronlimab, to 700 mg, to more closely mimic pre-clinical dosing. The next
review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Due
to the necessary prioritization of limited capital, enrollment under the amended protocol has been temporarily delayed
(
I'm not particularly interested in the many mysteries of the GvHD trial and its never-ending story at the moment, given that CD-12 readout is so close, but I will definitely dig into this more if we don't get a very favourable PR in January aka "Primary endpoint met". And I won't be satisfied with a PR trying to hide this news which contradicts the guidance given during previous presentations 6-8 weeks ago.
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