Our last post (catch up on it here) discussed the August 31, 2020 updates to the ongoing Covid trial run by everyone’s favorite reverse-merger pink sheet Coronacrapper, Cytodyn (CYDY). Together we looked at the strange disappearance of Yale and the complete absence of any trial sites in the UK. Some people complained that the curmudgeonly crew at BuyersStrike! HQ only looks at the negatives swirling around Cytodyn, and not the positives. “Why look at the sites that aren’t there, instead look at the sites that are there.” Spoiler Alert: Be careful what you wish for.
While we wait for The NaDDir’s* next ridiculous stock pumping conference call, scheduled for September 16th, let’s take a peek at one of the sites that is participating in Cytodyn’s trial of loserlimab in severe to critical Covid patients.
Recall that the list of trial sites is available here. One particular site sticks out from the others:
The impressively named Center for Advanced Research & Education has an equally impressive website here. CARE is run by Dr. Chris Recknor. Recknor’s involvement with Cytodyn was highlighted in an early July article from Stat (catch up on that article here).
Recruitment of patients started in April, but by early June, CytoDyn admitted publicly that enrollment stalled at 58 patients — 39 treated with leronlimab injections and 19 offered matching placebo injections. Days later, however, CytoDyn said it had managed to recruit, enroll and treat the full allotment of 75 patients with mild to moderate Covid-19.
CytoDyn credited the quick boost in patient enrollment to Chris Recknor, a physician and clinical trialist in Gainesville, Ga., who also was treated with leronlimab under a compassionate use protocol after being diagnosed with a more serious case of Covid-19. Recknor eventually recovered, although what role, if any, that leronlimab played is not known.
Recknor was “very grateful for CytoDyn’s efforts” and agreed to work for the company to recruit patients, said Scott Kelly, CytoDyn’s chairman and chief medical officer, on a June 11 conference call. “He has been a tremendous asset in enrolling our mild to moderate Covid-19 trial.”
The exact nature of Recknor’s patient recruitment work for CytoDyn is not clear. Recknor’s medical practice is called the Center for Advanced Research and Education. Recknor and his practice have participated in 10 clinical trials, mostly focused on treatments for osteoporosis and other bone disorders, his medical specialty, according to the government’s ClinicalTrials.gov database.From https://www.statnews.com/2020/07/08/a-moment-of-truth-arrives-for-cytodyns-covid-19-drug-dont-let-spin-obscure-it/
According to the Atlanta Journal-Constitution, when Dr. Recknor fell ill, he did not go to his own facility, rather he went to a hospital down the road:
If CARE is such a high tech facility that it can treat critical patients and also participate in clinical studies, certainly someone on staff could have checked out Dr. Recknor? Or is there even less to CARE than it seems?
Northeast Georgia Medical Center in Gainesville not only looks like a real hospital,
but it is also registered with the State of Georgia. You can search licensed Georgia Health Care Facilities here.
CARE, located at 2350 Limestone Parkway NE in Gainesville, is not nearly as impressive:
And if you search for the Center for Advanced Research & Education in State of Georgia records, no license can be found.
What if you search by address?
Still nothing. Recall the criteria for being included in this study:
Subjects must be hospitalized with severe or critical illness. Does CARE look like an inpatient facility equipped to care for patients in severe or critical condition? Ones at risk of ARDS?
Are Cytodyn study patients being hospitalized and then treated with an experimental medication in an unlicensed facility? Where is the IRB? The potential CFR Title 45 violations are staggering in their implications.
Interestingly, the Principal Investigator at the CARE site in the current Cytodyn study is not Dr. Chris Recknor, but Dr. Angela Ritter. She doesn’t show up on the CARE website:
Dr. Ritter is actually a family medicine specialist (Georgia license 42712) and her practice, according to State of Georgia records (search them yourself here), is located in a nearby town, Flowery Branch. From these records it also doesn’t appear that she has any hospital admitting privileges.
How can she possibly treat hospitalized Severe-to-Critical Covid-19 patients, with an experimental drug, in any facility let alone the unlicensed CARE site?
Readers may recall that previously we looked at a number of lawsuits against Cytodyn. One, by former Chief Medical Officer, and Vice Chairman, Dr. Richard Pestell is quite relevant. Refresh your memories here and here. Paragraphs 65 and 66 are the most important:
65. Specifically, on June 20, 2019, the CEO, who has no medical training, demanded that the clinical trial office at Amarex Clinical Research LLC (“Amarex”) “submit the IND and protocol that you had made for colon cancer for submission to the FDA by tomorrow and let [Professor] John [Marshall, Consultant to CytoDyn] know that we are not waiting for him any longer.”
66. Dr. Pestell pushed back on the CEO’s attempts to rush the submission because,the week prior, on June 12, 2019, Dr. Pestell had determined that the protocol was unsafePestell v Cytodyn (CYDY) 1:19-cv-01563-RGA
If Pestell is to be believed, Cytodyn has a history of conducting unsafe trials. While it is unlikely that the company will ever share the data, at the very least an analysis of patient enrollment and outcome by site is needed. If this clinical trial (NCT04347239) is being conducted in unlicensed facilities, putting patients lives at risk, a much closer look by both Georgia and Federal regulators may be in order.
THE CONTENT CONTAINED IN THIS BLOG REPRESENTS ONLY THE OPINIONS OF THE AUTHOR. THE AUTHOR MAY HOLD EITHER LONG OR SHORT POSITIONS IN SECURITIES OF VARIOUS COMPANIES DISCUSSED IN THE BLOG. THIS COMMENTARY IN NO WAY CONSTITUTES INVESTMENT ADVICE, AND SHOULD NEVER BE RELIED ON IN MAKING AN INVESTMENT DECISION, EVER. THIS BLOG IS NOT A SOLICITATION OF BUSINESS: ALL INQUIRIES WILL BE IGNORED. THE CONTENT HEREIN IS INTENDED SOLELY FOR THE ENTERTAINMENT OF THE READER, AND THE AUTHOR.