OUCH! This is only part of what I've seen today. Looks like the FDA did eff up, badly. Before you bashers spew any garbage. I suggest you find and read all the documents before you make yourselves look like the buch of morons that you are. It's a matter of time for partnerships as well as success for Leronlimab. Time for me to buy back in...heavily. Good luck shorts, you're going to need it. The email exchanges beween the FDA and Cytodyn are very biased and disturbing.
Dear Debra,
Please see attached the cytokine profiles from BL and day 3 in the first 4 icu patients treated at
Montefiore with Leronlimab. Remarkable declines in IL-6 and TNF alpha. Three of these 4 pts have
done well. Dr. Seetham believes the 4th Pt (with IL-6 above 1,000) succumbed due to a secondary
infection. We expect additional cytokine profiles on all 7 emergency IND pts by Monday. Dr. Bruce
Patterson, who ran the cytokine profiles, also has data showing trends toward normalization of
CD4/CD8 ratios by day 3 (and is cc’d above).
As you know, randomized clinical trials in both mild/moderate and severely ill patients will start
soon.
Sadly, we are on the verge of an unmitigated disaster threatening millions of lives. Given the known
benign safety profile of Leronlimab and the above cytokine results, one could reasonably hope that
early treatment with Leronlimab in hospitalized patients could reduce progression to ventilator
dependence in some or even many patients. Accordingly, my conscience compels me to propose 2
ideas:
First, Cytodyn would like permission to start enrolling pts on the phase II trial in patients with
Case 8:22-cr-00440-PX Document 118-1 Filed 04/08/24 Page 4 of 6
mild/moderate disease immediately. Our PI, Dr. Seetham, Is ready to start tonight.
Second, I’d like to propose the admittedly unprecedented idea of an emergency conditional approval
based on known safety and accumulating cytokine data. This would allow doctors to treat
hospitalized patients immediately and hopefully lessen the looming tidal wave of icu admissions for
ventilator support. Formal approval, of course, would remain conditional on the results of the RCTs.
Such conditional approval now would not entail any reimbursement to Cytodyn for providing drug in
this dire situation. Further, such conditional approval would not preclude clinicians from treating
their patients with other modalities or investigational antivirals.
We all know the drug is safe.
Those cytokine results strongly suggest this drug might help avert a national disaster associated with
ventilator shortages."
Respectfully,
Jay Lalezari, MD
Medical Director, Quest Research
Interim CMO, Cytodyn.
Cell:
From: Jay Lalezari <drjay@questclinical.com>
