Jeff Manning and Gilead's Long Arm?
So on July 30 Cytodyn publishes its Annual 10-K Report and the same day, within a few hours or even minutes, The Oregonian uploads that piece by Jeff Manning on federal investigation of Cytodyn. I wish to feel as sanguine, even dismissive as some of our investors about it. But I ask myself: Is it a pure coincidence that Jeff Manning--an "investigative reporter at @Oregonian, proud Oregon resident, family man, cyclist, avid reader and Husky alum"--had nothing better to do on Friday evening than digging out two paras in the 200+-page report (pp. 125-6) and making sure that the entire English-speaking world, let alone the good citizens of Oregon, know about the DOJ investigation. Just think of it! Jeff might have sacrificed a Friday barbeque family dinner for this feat of investigative journalism. Or was his piece ready to go well before our 10-K?
Also, I share Buddyboy's thoughts about the "liquidation" of Cytodyn for the sake of stealing LL. I just don't see InCellDX as the final destination for our molecule. They are too small for this diamond. A Gilead would squash Patterson's outlet even easier than Cytodyn.
Attached is a couple of quotes from the Report that be of interest, especially in view of our expectations for the BLA in HIV.
"Licensure and Regulation of Biological Products in the United States
In the United States, the FDA regulates human drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and in the
case of biological products, also under the Public Health Service Act, or the PHSA, and their implementing regulations. We believe that our
products will be regulated as biological products, or biologics. The failure to comply with the applicable U.S. requirements may result in
FDA refusal to approve pending BLAs or delays in development and may subject an applicant to administrative or judicial sanctions, such
as issuance of warning letters, or the imposition of fines, civil penalties, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions and/or civil or criminal prosecution brought by the FDA and the U.S. Department of Justice or other
governmental entities.
We may be at increased risk of becoming the target of cyber-attacks due to our research involving leronlimab for treatment of COVID19.
Cybersecurity authorities in the United States are currently investigating a number of incidents in which hackers are targeting
pharmaceutical companies, medical research organizations, and universities in order to steal sensitive research data and intellectual
property related to efforts to contain and treat coronavirus. In July 2020, the U.S. Department of Justice accused several groups of hackers
of targeting companies conducting COVID-19 vaccine development research on behalf of foreign intelligence services. Because of
leronlimab’s potential effect on the immune system, it has been administered to COVID patients under single patient Emergency
Investigation New Drug (EIND) authorizations, and the Company has initiated several clinical trials for COVID-19 in the U.S. and other
countries. As a result of our ongoing clinical trials for leronlimab to treat COVID-19, our information technology systems, employees,
contractors and corporate partners may be at greater risk for cyber-based attacks."
Who needs "foreign intelligence services" when we have our own Gileads right next to us?
So on July 30 Cytodyn publishes its Annual 10-K Report and the same day, within a few hours or even minutes, The Oregonian uploads that piece by Jeff Manning on federal investigation of Cytodyn. I wish to feel as sanguine, even dismissive as some of our investors about it. But I ask myself: Is it a pure coincidence that Jeff Manning--an "investigative reporter at @Oregonian, proud Oregon resident, family man, cyclist, avid reader and Husky alum"--had nothing better to do on Friday evening than digging out two paras in the 200+-page report (pp. 125-6) and making sure that the entire English-speaking world, let alone the good citizens of Oregon, know about the DOJ investigation. Just think of it! Jeff might have sacrificed a Friday barbeque family dinner for this feat of investigative journalism. Or was his piece ready to go well before our 10-K?
Also, I share Buddyboy's thoughts about the "liquidation" of Cytodyn for the sake of stealing LL. I just don't see InCellDX as the final destination for our molecule. They are too small for this diamond. A Gilead would squash Patterson's outlet even easier than Cytodyn.
Attached is a couple of quotes from the Report that be of interest, especially in view of our expectations for the BLA in HIV.
"Licensure and Regulation of Biological Products in the United States
In the United States, the FDA regulates human drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and in the
case of biological products, also under the Public Health Service Act, or the PHSA, and their implementing regulations. We believe that our
products will be regulated as biological products, or biologics. The failure to comply with the applicable U.S. requirements may result in
FDA refusal to approve pending BLAs or delays in development and may subject an applicant to administrative or judicial sanctions, such
as issuance of warning letters, or the imposition of fines, civil penalties, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions and/or civil or criminal prosecution brought by the FDA and the U.S. Department of Justice or other
governmental entities.
We may be at increased risk of becoming the target of cyber-attacks due to our research involving leronlimab for treatment of COVID19.
Cybersecurity authorities in the United States are currently investigating a number of incidents in which hackers are targeting
pharmaceutical companies, medical research organizations, and universities in order to steal sensitive research data and intellectual
property related to efforts to contain and treat coronavirus. In July 2020, the U.S. Department of Justice accused several groups of hackers
of targeting companies conducting COVID-19 vaccine development research on behalf of foreign intelligence services. Because of
leronlimab’s potential effect on the immune system, it has been administered to COVID patients under single patient Emergency
Investigation New Drug (EIND) authorizations, and the Company has initiated several clinical trials for COVID-19 in the U.S. and other
countries. As a result of our ongoing clinical trials for leronlimab to treat COVID-19, our information technology systems, employees,
contractors and corporate partners may be at greater risk for cyber-based attacks."
Who needs "foreign intelligence services" when we have our own Gileads right next to us?
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CytoDyn Inc (CYDY) Stock Research Links
Whatever happens, we have got
Le-Ron-Li-Mab, and they have not.
Le-Ron-Li-Mab, and they have not.
