Part 2: New Red Flags Emerge From Veru’s Phase 3 Covid Trial, Suggesting An FDA Rejection Is Likely – White Diamond Research
White Diamond Research exposes critical flaws in Veru's COVID-19 drug trial, revealing data integrity issues, methodological problems, and potential FDA rejection risks for sabizabulin treatment.
White Diamond Research's detailed analysis exposes critical flaws in Veru's sabizabulin COVID-19 treatment trial, revealing questionable data integrity, methodological issues, and conflicts of interest that signal probable FDA rejection.
Stock info:
- Ticker: VERU (NASDAQ)
- Position: White Diamond Research is short VERU and stands to benefit from price declines
Why it matters:
- Sabizabulin's mechanism of action, originally developed for cancer, lacks credible scientific evidence for COVID-19 efficacy, with Veru's Chief Science Officer admitting minimal research went into repurposing
- Trial design shows alarming randomization deficiencies with inadequate protocol details compared to industry standards, suggesting potential data manipulation
- Evidence indicates more severe COVID-19 cases were concentrated in the placebo group, artificially inflating efficacy results
- Longstanding relationships between Veru and key trial centers (particularly Inspira Medical Center) create significant conflicts of interest, compromising trial objectivity
- Unlike all successful COVID EUA recipients (companies with $60B+ market caps), Veru's $1.2B valuation and extended FDA review timeline signal regulatory concerns
- Parallels with Beyond Spring's rejected cancer drug suggest similar fate for Veru, as both drugs are tubulin disruptors with cardiovascular risk profiles
Between the lines:
- Veru's unusual decision to publish a peer-reviewed article during FDA review (not after) invites additional scrutiny and suggests anticipation of rejection
- Principal investigator at key trial site runs a ketamine/IV vitamin clinic and has ties to previous controversial biotech promotions
- With only 200 subjects enrolled, statistical anomalies and potential unblinding could significantly skew trial outcomes
- Every COVID treatment with extended FDA review timelines like Veru's has faced significant regulatory challenges or outright rejection
- Sabizabulin relies on a "colchicine-like" mechanism despite colchicine failing in a much larger (1,200 patient) COVID trial
FAQs:
Why is Veru's COVID-19 drug likely to be rejected by the FDA?
White Diamond Research identifies multiple red flags including questionable trial randomization, small sample size (200 patients), potential conflicts of interest with trial centers, and a drug mechanism lacking scientific rationale for COVID-19 treatment.
What is sabizabulin and how was it developed?
Sabizabulin is a tubulin disruptor originally developed as a cancer treatment. Veru hastily repurposed it for COVID-19 without substantial preclinical evidence, with the company's Chief Science Officer admitting the adaptation process took only a weekend.
How does Veru's trial compare to other successful COVID-19 treatments?
Unlike successful COVID-19 treatments that secured FDA approval, Veru's trial was significantly smaller (200 patients vs. thousands), lacked transparent randomization protocols, and came from a company with a much smaller market capitalization ($1.2B vs. $60B+).
What similarities exist between Veru's situation and Beyond Spring's rejected drug?
Both companies developed tubulin disruptors with similar cardiovascular risk profiles, both showed promising Phase 3 results initially, and both faced extended FDA reviews. Beyond Spring ultimately received an FDA rejection, causing its market value to collapse.
Why is publishing a peer-reviewed article during FDA review concerning?
Most pharmaceutical companies wait until after FDA decisions to publish peer-reviewed articles to avoid complicating the regulatory process. Veru's decision to publish during review is unusual and may indicate an attempt to build market support ahead of a negative FDA decision.
What specific trial design flaws does the report identify?
The report highlights inadequate randomization details, potential unblinding of patients, imbalances in COVID-19 severity between treatment and placebo groups, and lack of comprehensive sub-population analyses that would be standard in rigorous clinical trials.
Disclaimer
This summary is based on a report by White Diamond Research. For the full, detailed analysis, please refer to the original source material: https://whitediamondresearch.com/research/part-2-new-red-flags-emerge-from-verus-phase-3-covid-trial-suggesting-an-fda-rejection-is-likely/
ShortReport.fyi is not the author or originator of the content provided in this publication. We act solely as a distributor of the content and do not endorse, verify, or take responsibility for the accuracy, completeness, or reliability of the information presented. Each author retains full ownership and responsibility for their respective content, including any opinions, projections, or analyses expressed therein.
This publication is for informational purposes only and should not be construed as legal, business, investment, or tax advice. Readers are advised to consult the original source material and seek guidance from qualified professionals before making any decisions based on the information contained herein.
ShortReport.fyi disclaims all liability for any loss or damage arising from reliance on the content provided by third parties. The views expressed in these materials are solely those of the respective authors and do not necessarily reflect the views or opinions of ShortReport.fyi.