Thread by @IamBreastCancer

Cytodyn ($CYDY) has put out yet another press release touting "strong results" from their triple negative breast cancer (TNBC) Leronlimab research and their intent to "evolve into an oncology-focused company. As a TNBC patient & advocate (NOT an investor), I have some questions.

Headline mentions results from 30 mTNBC patients. How many mTNBC patients in total have been approved for Cytodyn trials? How many have received Leronlimab, including via EIND, EUA, phase I/II trial, compassionate use, etc? How many have died?

NCT03838367 How can a 30-pt single arm (no control group) study make conclusions re survival, PFS or OS? Increase in survival compared to WHAT, exactly? Historical mean overall survival varies widely.

Are these touted 300%/450% survival increases being attributed to a specific Leronlimab dosage? The switch from phase I to II was only announced 7 days earlier for MTD of 700mg used for phase II so 12-month results seem odd.

Why is Daniel Adams of Creatv MicroTech making statements on behalf of Cytodyn re trial results? Is Creatv formally involved w/this research? Is it acceptable to use UNPROVEN, UNAPPROVED tests to measure results in drug trial participants?

Is this a sales pitch for Creatv MicroTech, or an unbiased discussion of interim results from a cancer med trial? Is there any evidence that CAMLs and CTCs are clinically relevant or meaningful to patient outcomes?

Is this “large group” referring to some unspecified subset of the 30 patients in the trial? If so, how many, and what’s the status of the others?
Citation for that mPFS statistic? It seems to conflict with PMC7968109

How will any results obtained be attributable to the leronlimab itself, rather than to the carboplatin or the synergy between them, especially since at least one of the pts oncologist ordered termination of tmt w/ Carboplatin, to be on Leronlimab only as monotherapy?

"72% of pts had a decrease in cancer-associated macrophage-like cells (CAMLs) around 30 days after induction of leronlimab.” Which LL dosage? What is the clinical significance of decreased CAMLs? Citation? Does carboplatin itself have an effect on CAMLs/CTCs?

What is the breakdown of all participants according to RECIST v1.1 framework (per leronlimab trial registration)? Secondary outcome for trial “Phase II: Progression Free Survival (PFS) according to RECIST v1.1” Guidelines outlined on EORTC website, including important caveats:

TL/DR:"[Cytodyn]we have yet to deliver any significant results whatsoever, but you gave us your phone number so we'll plan to call you sometime to ask you to remind us yet again what steps we need to take in order to appear to be legitimately running a trial" #CargoCultScience

Do PR claims like “The fact that >70% of pts saw positive changes in circulating tumor cells after a single dose of leronlimab was made even more informative by their dramatic increases in both progression-free survival and overall survival” meet all applicable FDA and IRB rules?

Beyond this latest press release, though, I have some other questions about Cytodyn and leronlimab more generally. Again for the record, I'm not an investor or paid shill as some would accuse. I'm a concerned TNBC patient and advocate.

Cytodyn promoters and executives routinely make superfluous claims for leronlimab using adjectives like brilliant, stunning, spectacular. Do they fall within FDA guidelines for promotion of investigational drugs? SEC rules?

Are there any independent, unbiased TNBC oncologists or researchers who support/endorse this leronlimab trial and Cytodyn’s unconventional business practices?

Is it ethical for a pharmaceutical co. to publicly identify trial participants? eg Cytodyn welcoming a certain TNBC pt to their trial, promoting pts’ fundraising campaigns, or identifying a patient as the CEO’s own mother in law? Is that a conflict of interest? Exploitation?

How many lawsuits & legal challenges has Cytodyn and associated employees, executives, and associated personnel faced? What is the current status of each?

Is it acceptable practice for a trial participant (Dr Chris Recknor) who is also a physician and owner of a clinic running said trials, to become COO and head of clinical research and continue treating trial patients?

Is there any ethical breach or COI when Cytodyn appoints Dr Jay Lalezari as CMO while also serving as CEO of Quest Clinical & serving as leading clinician for Leronlimab trials, including the golden goose TNBC trial (particularly in light of the fact he is not an oncologist)?

Is there any ethical breach or COI involving Dr Norman Gaylis serving on Cytodyn’s board of scientific advisors while also owning a clinic, serving as principal investigator of a leronlimab trial and recruiting via exploitational enrolled patient youtube videos?

What is the detailed history/timeline of FDA applications and outcomes of each, regarding BTD, BLA, EUA and Fast Track designations, clarified for lay audience? Paid PR promos seem to offer conflicting details. Small sample here:

Has Cytodyn managed to obtain official FDA approval for Leronlimab aka Vyrologix aka Pro-140 for *any* disease or indication in the last decade-plus, despite endless hype about multiple “shots on goal?” Why?

Why did FDA find it necessary to issue an unprecedented and blistering public reprimand for Cytodyn regarding their trial conduct and public messaging in May 2021?

Why is leronlimab discussion space online overwhelmingly populated by $CYDY investors, trolls, sockpuppets and bullies, instead of by medical professionals, journalists, and legitimate researchers? #FoodForThought

How many Cytodyn trial researchers, doctors, execs, promoters, etc are or have been financially invested with CYDY stock shares? Are all potential COIs appropriately managed and disclosed?

Cytodyn proudly announced formation of a Scientific Advisory Board in Sept 2020. Are they compensated by Cytodyn? Have any of these members spoken publicly about their involvement and/or their personal or professional views of Leronlimab?

Given this graph of avg "H-scores" for CCR5 showing very low bar for TNBC, what is the significance of this data in terms of Cytodyn's decision to focus on triple negative breast cancer for leronlimab?

At least three breast cancer patients, two of which DIED on Cytodyn's trial, were receiving twice-weekly leronlimab dosing, but the trial registration indicates weekly injections. Does @US_FDA allow dosing outside of the protocol registered?